Devices › Catheter, percutaneous
Device brand name · Cto catheter systems dqy
Outback Re-Entry Catheter: medical device reports filed with FDA
275 reports name it, 2006–2016. Manufacturer given most often on reports: Cordis De Mexico. Product code DQY.
- 275
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 84%
- classified as malfunction
- 74.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
275 medical device reports received by FDA name the brand "Outback Re-Entry Catheter" (cto catheter systems dqy); the manufacturer given most often on reports is Cordis De Mexico; received from April 2006 to May 2016. 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 (84%) and injury (16%); 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 retraction problem (45.8%), fracture (16%) and difficult to remove (14.2%). The patient problems coded most often are therapy/non-surgical treatment, additional, foreign body in patient and foreign body, removal of. 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 Outback Re-Entry Catheter was received in the five years to August 2026; the latest was received in May 2016.
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 |
|---|---|---|---|
| Retraction problem | 126 | 45.8% | 2.3% |
| Fracturea broken bone | 44 | 16% | 2.6% |
| Difficult to removethe device was hard to remove | 39 | 14.2% | 4.1% |
| Detachment of device component | 29 | 10.5% | 2.2% |
| Material separation | 23 | 8.4% | 4.1% |
| Device, removal of (non-implant) | 11 | 4% | 0.4% |
| Replace | 11 | 4% | 0.4% |
| Breakthe device broke | 10 | 3.6% | 9.2% |
| Difficult to insertthe device was hard to insert | 6 | 2.2% | 1.2% |
| Physical resistance | 6 | 2.2% | 1.3% |
| Sticking | 6 | 2.2% | 0.5% |
| Other (for use when an appropriate device code cannot be identified) | 5 | 1.8% | 0.5% |
| Device difficult to setup or prepare | 4 | 1.5% | 0% |
| Kinkedthe tube or line kinked | 4 | 1.5% | 3.4% |
| Tear, rip or hole in device packaging | 4 | 1.5% | 0.2% |
| Device, or device fragments remain in patient | 3 | 1.1% | 0.1% |
| Interference | 3 | 1.1% | 0% |
| Packaging problem | 3 | 1.1% | 0.3% |
| Unsealed device packaging | 3 | 1.1% | 0.2% |
| Delivered as unsterile product | 2 | 0.7% | 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 |
|---|---|---|
| Therapy/non-surgical treatment, additional | 14 | 5.1% |
| Foreign body in patientpart of a device left in the patient | 9 | 3.3% |
| Foreign body, removal of | 9 | 3.3% |
| No patient involvement | 9 | 3.3% |
| Device embedded in tissue or plaque | 8 | 2.9% |
| Nonresorbable materials, unretrieved in body | 7 | 2.5% |
| Surgical procedure aborted/stopped | 5 | 1.8% |
| Injurya physical injury | 3 | 1.1% |
| Surgical procedure, additional | 2 | 0.7% |
| Bleeding | 1 | 0.4% |
| Great vessel perforation | 1 | 0.4% |
| Hypovolemia | 1 | 0.4% |
| Hypovolemic shock | 1 | 0.4% |
| Occlusion | 1 | 0.4% |
| Other (for use when an appropriate patient code cannot be identified) | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Outback Re-Entry Catheter | Product code DQY | All MAUDE reports |
|---|---|---|---|
| Reports | 275 | 41,793 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 22 | 9 |
| Classified as injury | 16% | 22.7% | 36.2% |
| Classified as malfunction | 84% | 74.7% | 62.3% |
| Filed by the manufacturer | 99.6% | 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% |
| Sterling Balloon Dilatation Catheter | 488 | 0 | 0.4% |
| 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% |
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 Outback Re-Entry Catheter reports
How many FDA reports name Outback Re-Entry Catheter?
275 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 (84%) and injury (16%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
retraction problem (45.8%), fracture (16%), difficult to remove (14.2%), detachment of device component (10.5%) and material separation (8.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Outback Re-Entry 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.