MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-09-23 for BYRD DILATOR SHEATH SET TEFLON LR-TEFBES LR-TEFBES 002 manufactured by Cook Pacemaker Corp..
[20676]
While extracting a chronic, ventricular pacing electrode of another mfr via the left subclavian, a teflon dilator inner sheath was utilized inside a stainless steel dilator because the outer teflon sheath of the dilator set could not be advanced due to fibrin within the vein. While attempting advancement of this metal over teflon dilator combination, a narrow, eight centimeter long sliver was sliced longitudinally from the teflon sheath. The pacing electrode was then extracted using the femoral route. The insulation of the electrode was found to be broken with resultant exposure and distension of the metal conductor helix. The portion of the teflon sheath was then surgically removed from the subclavian. The chest tube was inserted.
Patient Sequence No: 1, Text Type: D, B5
[17983085]
File no. 1225
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2522007-1996-00001 |
| MDR Report Key | 39789 |
| Report Source | 07 |
| Date Received | 1996-09-23 |
| Date of Report | 1996-08-30 |
| Date of Event | 1996-08-28 |
| Date Mfgr Received | 1996-08-30 |
| Device Manufacturer Date | 1996-04-01 |
| Date Added to Maude | 1996-09-30 |
| 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 TEFLON |
| Generic Name | CATHETER RETRIEVAL DEVICE |
| Product Code | GCC |
| Date Received | 1996-09-23 |
| Model Number | LR-TEFBES |
| Catalog Number | LR-TEFBES 002 |
| Lot Number | 20254 |
| ID Number | NA |
| Device Expiration Date | 1999-04-01 |
| 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 | 40921 |
| Manufacturer | COOK PACEMAKER CORP. |
| Manufacturer Address | 9. O. BOX 529 RTE 66 RIVER RD LEECHBURG PA 15656 US |
| Baseline Brand Name | BYRD DILATOR SHEATH SET TEFLON 003-XL (EXTRA LONG) |
| Baseline Generic Name | CATHETER, SHEATH, DILATOR, RETRIEVER |
| Baseline Model No | LR-TEFBES |
| Baseline Catalog No | LR-TEFBES |
| Baseline ID | 003-XL |
| 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 | 1996-09-23 |