MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for OUTBACK ELITE RE-ENTRY CATHETER OTB59120A manufactured by Cordis Corporation.
[177381761]
During attempted pta of sfa, a reentry balloon and the outback reentry catheter was used. The operator of the catheter was unable to deliver the outback reentry catheter due to the acute angle of the aortic bifurcation. When they tried to remove the outback catheter, the plastic tip of that catheter broke loose and that piece was redirected into a small branch of the left profunda. The procedure was then terminated due to the inability to get intraluminal access into the right popliteal. The plastic tip is approx 2mm. The tip will remain in the pt. No attempt will be made to remove the plastic tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9653697 |
| MDR Report Key | 9653697 |
| Date Received | 2020-01-31 |
| Date of Report | 2019-09-20 |
| Date of Event | 2019-09-18 |
| Date Facility Aware | 2019-09-18 |
| Report Date | 2019-09-20 |
| Date Reported to Mfgr | 2019-09-20 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OUTBACK ELITE RE-ENTRY CATHETER |
| Generic Name | OUTBACK ELITE RE-ENTRY CATHETER |
| Product Code | PDU |
| Date Received | 2020-01-31 |
| Catalog Number | OTB59120A |
| Lot Number | 17843479 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | 7000 CARDINAL PLACE DUBLIN OH 430171091 US 430171091 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |