MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-05-14 for BYRD DILATOR SHEATH SET, POLYPROPYLENE LR-PPLBES LR-PPLBES10.0 manufactured by Cook Vascular Inc..
[131978]
Four pacing leads were successfully extracted. One of the leads had been recalled due to an atrial j forming wire puncturing through the lead's insulation with the risk of cardiac tamponade. A variety of extraction tools were utilized. The closing of the incision was complicated by pericardial tamponade.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2522007-1999-00010 |
| MDR Report Key | 223165 |
| Report Source | 05 |
| Date Received | 1999-05-14 |
| Date of Report | 1999-04-13 |
| Date of Event | 1998-11-10 |
| Date Mfgr Received | 1999-04-13 |
| Date Added to Maude | 1999-05-18 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BYRD DILATOR SHEATH SET, POLYPROPYLENE |
| Generic Name | CATHETER RETRIEVAL DEVICE |
| Product Code | GCC |
| Date Received | 1999-05-14 |
| Model Number | LR-PPLBES |
| Catalog Number | LR-PPLBES10.0 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 216426 |
| Manufacturer | COOK VASCULAR INC. |
| Manufacturer Address | P.O. BOX 529 ROUTE 66 RIVER RD. LEECHBURG PA 15656 US |
| Baseline Brand Name | BYRD EXTRACTOR SET |
| Baseline Generic Name | CATHETER, SHEATH, DILATOR, RETRIEVER |
| Baseline Model No | LR-PPLBES |
| Baseline Catalog No | LR-PPLBES002 |
| Baseline ID | NA |
| Baseline Device Family | DILATOR SHEATH |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K893480 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-05-14 |