Devices › Syringe, balloon inflation
Device brand name · Syringe balloon inflation
Advantage Balloon Catheter Inflation Device: medical device reports filed with FDA
288 reports name it, 2010–2018. Manufacturer given most often on reports: Boston Scientific - Cork. Product code MAV.
- 288
- device reports naming the brand
- 0% of all MAUDE reports · about 17 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 97.2%
- classified as malfunction
- 97% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 288 reports that name the brand "Advantage Balloon Catheter Inflation Device" (syringe balloon inflation), received between January 2010 and January 2018; the manufacturer given most often on reports is Boston Scientific - Cork. Spellings of one product vary from report to report.
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 (97.2%), injury (2.4%) and death (0.3%); across all syringe, balloon inflation reports (product code MAV) death is recorded in 0.2% and malfunction in 97%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device damaged by another device (54.2%), device contamination with chemical or other material (6.9%) and display or visual feedback problem (5.9%). The patient problems coded most often are no patient involvement, blood loss and cardiac arrest. 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 Advantage Balloon Catheter Inflation Device was received in the five years to August 2026; the latest was received in January 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,685 reports carrying product code MAV. 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 |
|---|---|---|---|
| Device damaged by another device | 156 | 54.2% | 4.3% |
| Device contamination with chemical or other material | 20 | 6.9% | 3.3% |
| Display or visual feedback problem | 17 | 5.9% | 9.4% |
| Unable to obtain readings | 16 | 5.6% | 2.3% |
| Device packaging compromised | 12 | 4.2% | 3% |
| Inflation problem | 10 | 3.5% | 3.7% |
| No display/image | 7 | 2.4% | 0.8% |
| Breakthe device broke | 5 | 1.7% | 7.8% |
| Detachment of device component | 3 | 1% | 0.7% |
| Difficult to open or remove packaging material | 3 | 1% | 0.2% |
| Leak/splashthe device leaked | 3 | 1% | 36.3% |
| Device contamination with biological material | 2 | 0.7% | 0.1% |
| Device damaged prior to usethe device was damaged before use | 2 | 0.7% | 0.7% |
| Incorrect measurementthe device measured wrongly | 2 | 0.7% | 5.6% |
| Sticking | 2 | 0.7% | 0.7% |
| Tear, rip or hole in device packaging | 2 | 0.7% | 1.7% |
| Crackthe device cracked | 1 | 0.3% | 0.5% |
| Decrease in pressure | 1 | 0.3% | 0.1% |
| Detachment of device or device componentpart of the device came off | 1 | 0.3% | 0.4% |
| Difficult to open or close | 1 | 0.3% | 0% |
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 |
|---|---|---|
| No patient involvement | 58 | 20.1% |
| Blood loss | 3 | 1% |
| Cardiac arrestthe heart stopped | 1 | 0.3% |
| Cardiac tamponade | 1 | 0.3% |
| Cardiogenic shockshock from the heart failing to pump | 1 | 0.3% |
| Deaththe patient died; cause not stated by this term | 1 | 0.3% |
| Intimal dissection | 1 | 0.3% |
| Perforation | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Advantage Balloon Catheter Inflation Device | Product code MAV | All MAUDE reports |
|---|---|---|---|
| Reports | 288 | 3,685 | 26,136,888 |
| Share of that pool | — | 7.8% | 0% |
| Classified as death, per 1,000 reports | 3 | 2 | 9 |
| Classified as injury | 2.4% | 2.5% | 36.2% |
| Classified as malfunction | 97.2% | 97% | 62.3% |
| Filed by the manufacturer | 100% | 98% | 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 MAV
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| 20/30 Priority Pack Indeflator | 571 | 0 | 0% |
| Indeflator | 356 | 23 | 0% |
| Encore Balloon Catheter Inflation Device | 323 | 0 | 0% |
| 20/30 Priority Pack W/Copilot | 275 | 0 | 0% |
| 20/30 Priority Pack Accessory Kit | 157 | 0 | 0% |
| Boston Scientific | 580 | 5 | 3.3% |
| Medex | 202 | 8 | 0% |
| Polarcath | 164 | 0 | 3.7% |
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 Advantage Balloon Catheter Inflation Device reports
How many FDA reports name Advantage Balloon Catheter Inflation Device?
288 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 (97.2%), injury (2.4%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device damaged by another device (54.2%), device contamination with chemical or other material (6.9%), display or visual feedback problem (5.9%), unable to obtain readings (5.6%) and device packaging compromised (4.2%). 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 Advantage Balloon Catheter Inflation Device 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.