MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-09-26 for 5.5F TEC CORONARY ATHERECTOMY SYSTEM C101855 manufactured by Interventional Technologies, Inc..
[90199]
During use of a 5. 5f tec coronary atherectomy catheter in a pt's saphenous vein bypass graft, the physician observed a perforation in the graft wall. Thereafter, it was observed that the cutter had detached from the distal tip of the tec catheter. The cutter was retrieved by withdrawing the tec guidewire, which contains a fail-safe mechanism to prevent embolization of the cutter. Ptca and stent implantation were performed to stop bleeding from the perforation site. In addition, the pt underwent surgical intervention to repair the perforation site. Thereafter, the pt was discharged without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024805-1997-00001 |
| MDR Report Key | 125279 |
| Report Source | 05 |
| Date Received | 1997-09-26 |
| Date of Report | 1997-09-25 |
| Date of Event | 1997-08-27 |
| Date Mfgr Received | 1997-08-27 |
| Device Manufacturer Date | 1996-08-01 |
| Date Added to Maude | 1997-10-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5.5F TEC CORONARY ATHERECTOMY SYSTEM |
| Generic Name | CORONARY ATHERECTOMY SYSTEM |
| Product Code | MLX |
| Date Received | 1997-09-26 |
| Returned To Mfg | 1997-09-04 |
| Model Number | C101855 |
| Catalog Number | NA |
| Lot Number | F9620701 |
| ID Number | NA |
| Device Expiration Date | 1998-08-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 122638 |
| Manufacturer | INTERVENTIONAL TECHNOLOGIES, INC. |
| Manufacturer Address | 3574 RUFFIN RD. SAN DIEGO CA 92123 US |
| Baseline Brand Name | 5.5F TEC CORONARY ATHERECTOMY SYSTEM |
| Baseline Generic Name | CORONARY ATHERECTOMY SYSTEM |
| Baseline Model No | C101855 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | TEC CORONARY CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9100 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-09-26 |