MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 2007-04-27 for D-STAT FLOWABLE HEMOSTAT 4000 * manufactured by Vascular Solutions, Inc..
[629190]
A liver biopsy was performed and d-stat flowable was deployed into the tissue tract with no reported complications. The pt returned to the physician approx 8 days after the biopsy with a low grade fever and severe pain. An ultrasound examination showed a mass around the gall bladder area and the pt was admitted to the hosp for add'l tests which determined that the mass was due to the flowable being injected into the bile duct instead of the liver biopsy tissue tract. As of 2007, the pt was stable but still in the hospital under observation. Please note that use of the d-stat flowable product in this manner represented an off-label use of the product.
Patient Sequence No: 1, Text Type: D, B5
[7927558]
The device was used for an unapproved indication.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134812-2007-00005 |
| MDR Report Key | 842961 |
| Report Source | 04,05,06,07 |
| Date Received | 2007-04-27 |
| Date of Report | 2007-04-27 |
| Date of Event | 2007-04-10 |
| Date Mfgr Received | 2007-04-18 |
| Date Added to Maude | 2007-05-02 |
| 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 | JULIE TAPPER |
| Manufacturer Street | 6464 SYCAMORE CT. |
| Manufacturer City | MINNEAPOLIS MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7636564228 |
| 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 |
| Generic Name | TOPICAL HEMOSTAT |
| Product Code | MHW |
| Date Received | 2007-04-27 |
| Model Number | 4000 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 830097 |
| Manufacturer | VASCULAR SOLUTIONS, INC. |
| Manufacturer Address | * MINNEAPOLIS MN 55369 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-04-27 |