MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-10-03 for BYRD DILATOR SHEATH SET LR-PPLBES LR-PPLBES 10.0 manufactured by Cook Pacemaker Corporation.
[23061]
A recalled, four year old, atrial, j-wire, bipolar, retractable screw pacemaker electrode (lead) of a different mfr was being extracted because the j-wire had fractured and was protruding through the outer insulation. After successful positioning of the locking stylet and advancement of a teflon dilator sheath set, the distal tip of the electrode came free of its endocardial attachment. However, the very tip appeared to be joined to the chronic ventricular lead by fibrin. The teflon outer sheath was replaced with a polypropylene outer sheath in an attempt to free the electrode tip. Because of the distended condition of the lead, constant tension along the entire lead body was difficult to maintain as the outer sheath was advanced. At this point, slight prolapse of the vein was noted and the pt's blood pressure fell. The pt was immediately taken to an operating room but resuscitation was unsuccesful. An examination found a three inch tear in the innominate vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2522007-1996-00003 |
| MDR Report Key | 41482 |
| Report Source | 07 |
| Date Received | 1996-10-03 |
| Date of Report | 1996-09-16 |
| Date of Event | 1996-09-16 |
| Date Mfgr Received | 1996-09-16 |
| Device Manufacturer Date | 1996-05-01 |
| Date Added to Maude | 1996-10-09 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BYRD DILATOR SHEATH SET |
| Generic Name | CATHETER RETRIEVAL DEVICE |
| Product Code | GCC |
| Date Received | 1996-10-03 |
| Model Number | LR-PPLBES |
| Catalog Number | LR-PPLBES 10.0 |
| Lot Number | 20958 |
| ID Number | * |
| Device Expiration Date | 1999-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 42561 |
| Manufacturer | COOK PACEMAKER CORPORATION |
| Manufacturer Address | P. O. BOX 529 RTE 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. Death | 1996-10-03 |