MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-10-18 for BYRD DILATOR SHEATH SET LR-TEFBES LR-TEFBES 002 manufactured by Cook Pacemaker Corp..
[27551]
A recalled, four yr old, atrial, j-wire, bipolar, retractable screw pacemaker electrode (lead) of a different mfr was extracted. On the case report utilized for the mfr's lead extraction data base, the physician reported a tamponade/hemopericardium complication. In addition, to the mfr's instruments, an investigational laser device was utilized. The comment section of the form contained the following: despite very simple and easy advancement of sheath to right atrial myocardium pt developed atrial tear with cardiac tamponade requiring sternotomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2522007-1996-00004 |
| MDR Report Key | 44954 |
| Report Source | 05 |
| Date Received | 1996-10-18 |
| Date of Report | 1996-10-15 |
| Date of Event | 1996-10-09 |
| Date Facility Aware | 1996-10-09 |
| Date Mfgr Received | 1996-10-15 |
| Date Added to Maude | 1996-10-30 |
| 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 | 1996-10-18 |
| Model Number | LR-TEFBES |
| Catalog Number | LR-TEFBES 002 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 45858 |
| Manufacturer | COOK PACEMAKER CORP. |
| Manufacturer Address | P.O. BOX 529 RTE 66 RIVER RD. LEECHBURG PA 15656 US |
| Baseline Brand Name | BYRD DILATOR SHEATH SET TEFLON 002 |
| Baseline Generic Name | CATHETER, SHEATH, DILATOR, RETRIEVER |
| Baseline Model No | LR-TEFBES |
| Baseline Catalog No | LR-TEFBES |
| Baseline ID | 002 |
| 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 | 1996-10-18 |