MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-30 for BAXTER 9 FRENCH MULTILUMEN CATHETER M3L 9FHK1 * manufactured by Baxter Healthcare Corp..
[158561]
Pt with 9 french multilumen catheter placed during heart surgery experienced a neurological event during rewiring of the catheter postoperatively. Ct scan showed a thrombus in the right internal carotid artery which was treated with intra-arterial t-pa. Despite aggressive therapy, the pt experienced progressive left brain swelling and eventually slipped into a coma and died. The family refused autopsy. The co was notified immediately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 242803 |
| MDR Report Key | 242803 |
| Date Received | 1999-09-30 |
| Date of Report | 1999-09-27 |
| Date of Event | 1999-08-24 |
| Date Facility Aware | 1999-08-24 |
| Report Date | 1999-09-27 |
| Date Reported to FDA | 1999-09-27 |
| Date Reported to Mfgr | 1999-09-27 |
| Date Added to Maude | 1999-10-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAXTER 9 FRENCH MULTILUMEN CATHETER |
| Generic Name | CATHETER |
| Product Code | JCY |
| Date Received | 1999-09-30 |
| Model Number | M3L 9FHK1 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 235232 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | ONE BAXTER PKWY DEERFIELD IL 600154633 US |
| Baseline Brand Name | ADVANCED VENOUS ACCESS (AVA) CATHETER |
| Baseline Generic Name | CENTRAL VENOUS ACCESS CATHETER |
| Baseline Model No | M3L9FHKI |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K981909 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1999-09-30 |