Devices › Catheter, percutaneous
Device brand name · Catheter percutaneous
Sterling Balloon Dilatation Catheter: medical device reports filed with FDA
488 reports name it, 2009–2018. Manufacturer given most often on reports: Boston Scientific - Maple Grove. Product code DQY.
- 488
- device reports naming the brand
- 0% of all MAUDE reports · about 29 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 80.7%
- classified as malfunction
- 74.7% across the product code
- 0.4%
- classified as death, as reported
- 2 reports · not verified by FDA
488 medical device reports received by FDA name the brand "Sterling Balloon Dilatation Catheter" (catheter percutaneous); the manufacturer given most often on reports is Boston Scientific - Maple Grove; received from November 2009 to August 2018. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (80.7%), injury (18.9%) and death (0.4%); across all catheter, percutaneous reports (product code DQY) death is recorded in 2.2% and malfunction in 74.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material rupture (71.1%), deflation problem (2%) and difficult to remove (1.8%). The patient problems coded most often are hematoma, vasoconstriction and intimal dissection. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Sterling Balloon Dilatation Catheter was received in the five years to August 2026; the latest was received in August 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 41,793 reports carrying product code DQY. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Material rupture | 347 | 71.1% | 16.9% |
| Deflation problem | 10 | 2% | 2.7% |
| Difficult to removethe device was hard to remove | 9 | 1.8% | 4.1% |
| Burst container or vessel | 6 | 1.2% | 1.5% |
| Entrapment of device | 6 | 1.2% | 1.3% |
| Inflation problem | 6 | 1.2% | 1.3% |
| Breakthe device broke | 4 | 0.8% | 9.2% |
| Detachment of device or device componentpart of the device came off | 4 | 0.8% | 4.6% |
| Failure to advance | 4 | 0.8% | 2.6% |
| Hole in material | 4 | 0.8% | 0.5% |
| Sticking | 3 | 0.6% | 0.5% |
| Stretched | 3 | 0.6% | 0.5% |
| Device markings/labelling problema problem with the device markings or label | 2 | 0.4% | 0.3% |
| Device slipped | 2 | 0.4% | 0.1% |
| Insufficient device problem information | 2 | 0.4% | 0.9% |
| Leak/splashthe device leaked | 2 | 0.4% | 4.6% |
| Positioning problem | 2 | 0.4% | 0.3% |
| Air leak | 1 | 0.2% | 0.1% |
| Difficult to advance | 1 | 0.2% | 1.8% |
| Difficult to insertthe device was hard to insert | 1 | 0.2% | 1.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hematomaa collection of blood under the skin or in tissue | 23 | 4.7% |
| Vasoconstriction | 16 | 3.3% |
| Intimal dissection | 5 | 1% |
| Low blood pressure/ hypotension | 4 | 0.8% |
| Cardiac arrestthe heart stopped | 3 | 0.6% |
| Rupturethe device burst | 3 | 0.6% |
| Stroke/cva | 3 | 0.6% |
| Bradycardiaslow heart rate | 2 | 0.4% |
| Deaththe patient died; cause not stated by this term | 2 | 0.4% |
| Device embedded in tissue or plaque | 2 | 0.4% |
| No patient involvement | 2 | 0.4% |
| Obstruction/occlusion | 2 | 0.4% |
| Painpain, site not specified | 2 | 0.4% |
| Perforation of vessels | 2 | 0.4% |
| Pseudoaneurysm | 2 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sterling Balloon Dilatation Catheter | Product code DQY | All MAUDE reports |
|---|---|---|---|
| Reports | 488 | 41,793 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 4 | 22 | 9 |
| Classified as injury | 18.9% | 22.7% | 36.2% |
| Classified as malfunction | 80.7% | 74.7% | 62.3% |
| Filed by the manufacturer | 100% | 97.4% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code DQY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sterling | 4,963 | 300 | 0.1% |
| Deflect | 1,021 | 247 | 0.1% |
| Guidezilla | 1,018 | 0 | 0% |
| Lantern Delivery Microcatheter | 887 | 19 | 0% |
| WATCHMAN FXD Curve Access System | 973 | 198 | 9.6% |
| Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm | 1,406 | 170 | 0.1% |
| Coyote? | 1,767 | 122 | 0.1% |
| Advance 35 Lp Low Profile Balloon Catheter | 572 | 15 | 0.5% |
| Conquest Pta Dilatation Catheter | 505 | 0 | 0.2% |
| WATCHMAN TruSeal Access System | 716 | 50 | 8% |
| React catheter | 516 | 41 | 18.4% |
| Conquest Pta Balloon Dilatation Catheter | 510 | 0 | 0.2% |
| Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm | 1,110 | 123 | 0.1% |
| Neuron Max 6f 088 Long Sheath | 389 | 0 | 0.5% |
| WATCHMAN TruSteer? Access System | 401 | 260 | 9.2% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Sterling Balloon Dilatation Catheter reports
How many FDA reports name Sterling Balloon Dilatation Catheter?
488 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (80.7%), injury (18.9%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material rupture (71.1%), deflation problem (2%), difficult to remove (1.8%), burst container or vessel (1.2%) and entrapment of device (1.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Sterling Balloon Dilatation Catheter was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.