MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2004-08-16 for D-STAT FLOWABLE HEMOSTAT (USA) 4000 0330 manufactured by Vascular Solutions, Inc..
[19158927]
The patient was being treated as an outpatient with ptca in the distal circumflex region. The physician deployed a taxus (boston scientific) stent then experienced difficulties in removal of the balloon. After removal of the balloon, extravasation from a dissection near the guidewire tip was noted. The patient was bleeding into the pericardium. A pericardial centesis tray was used and approximately 350cc of blood was removed from the pericardium. Several attempts to resolve the bleeding were made by using balloon inflation to tamponade the site of dissection. This did not resolve the bleeding. By this time surgeon had been alerted. Delivery of a gel-foam product was attempted but the gel foam would not go through the catheter. As a last resort the physician attempted to close the dissection with delivery of the d-stat flowable. He positioned a balloon, inflated it and removed the wire. The d-stat flowable was delivered through the wire lumen. Due to the high pressure required to deliver the procoagulant through the wire lumen, the balloon slipped proximally and the procoagulant seeped into the lad as well as the proximal circumflex. The physician was aware that the d-stat flowable was not indicated for this treatment. The physician and staff attempted for approx 30 minutes to resuscitate the pt using techniques such as pacer, a balloon pump and intubation, all of which were unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134812-2004-00437 |
| MDR Report Key | 538799 |
| Report Source | 05,06,07 |
| Date Received | 2004-08-16 |
| Date of Report | 2004-08-16 |
| Date of Event | 2004-07-28 |
| Date Mfgr Received | 2004-07-28 |
| Date Added to Maude | 2004-08-16 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SARA COON, SR. ASSOCIATE |
| Manufacturer Street | 6464 SYCAMORE COURT |
| Manufacturer City | MINNEAPOLIS MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7636564300 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-STAT FLOWABLE HEMOSTAT (USA) 4000 |
| Generic Name | SEALING DEVICE |
| Product Code | MHW |
| Date Received | 2004-08-16 |
| Model Number | 4000 |
| Catalog Number | 0330 |
| Lot Number | 300787 |
| ID Number | NA |
| Device Expiration Date | 2004-12-31 |
| 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 | 528071 |
| Manufacturer | VASCULAR SOLUTIONS, INC. |
| Manufacturer Address | 6464 SYCAMORE COURT MINNEAPOLIS MN 55369 US |
| Baseline Brand Name | D-STAT FLOWABLE HEMOSTAT |
| Baseline Generic Name | TOPICAL HEMOSTAT |
| Baseline Model No | 4000 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9900 |
| Baseline 510K PMN | Y |
| Premarket Notification | K012293 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 7 | 1. Death | 2004-08-16 |