MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-01-06 for BYRD DILATOR SHEATH SET, POLYPROPYLENE LR-PPLBES LR-PPLBES11.5 manufactured by Cook Vascular Inc.
[16031136]
While extracting a 25 month old lead, the dr experienced a complication. Experiencing difficulty passing the polypropylene sheath set into the left subclavian vein, he removed the outer polypropylene sheath and replaced it with the outer sheath of a stainless steel sheath set. Having achieved access to the lumen, he encountered significant scarring, and so elected to continue advancing the stainless steel outer sheath over the polypropylene inner sheath. In the process, he transected the inner sheath with the sharp outer sheath. The pt was transferred to surgery, where the remnants of the sheath and the lead were successfully removed. The pt recovered uneventfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2522007-1999-00029 |
| MDR Report Key | 257818 |
| Report Source | 05 |
| Date Received | 2000-01-06 |
| Date of Report | 1999-12-10 |
| Date of Event | 1999-12-06 |
| Date Mfgr Received | 1999-12-10 |
| Date Added to Maude | 2000-01-11 |
| 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 |
| Manufacturer Contact | RICHARD SHIREY |
| Manufacturer Street | ROUTE 66 RIVER RD P.O. BOX 529 |
| Manufacturer City | LEECHBURG PA 15656 |
| Manufacturer Country | US |
| Manufacturer Postal | 15656 |
| Manufacturer Phone | 7248458621 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2000-01-06 |
| Model Number | LR-PPLBES |
| Catalog Number | LR-PPLBES11.5 |
| 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 | 249663 |
| Manufacturer | COOK VASCULAR INC |
| Manufacturer Address | ROUTE 66 RIVER RD P.O. BOX 529 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 | 2000-01-06 |