MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-10-01 for D-STAT FLOWABLE HEMOSTAT 4000 manufactured by Vascular Solutions, Inc..
[4922660]
D-stat flowable was used during a patient procedure involving the removal of a perma catheter. Upon removal of the perma catheter, the physician injected d-stat flowable at the insertion site and into the subclavian vein. Soon after injecting the d-stat flowable, the patient arrested and expired.
Patient Sequence No: 1, Text Type: D, B5
[12205879]
Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134812-2014-00038 |
| MDR Report Key | 4133307 |
| Report Source | 06,07 |
| Date Received | 2014-10-01 |
| Date of Report | 2014-09-11 |
| Date of Event | 2014-09-10 |
| Date Mfgr Received | 2014-09-11 |
| Date Added to Maude | 2014-10-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RENEE RUNTSCH |
| Manufacturer Street | 6464 SYCAMORE COURT NORTH |
| Manufacturer City | MAPLE GROVE MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7636564366 |
| Manufacturer G1 | VASCULAR SOLUTIONS, INC. |
| Manufacturer Street | 6464 SYCAMORE COURT NORTH |
| Manufacturer City | MAPLE GROVE MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55369 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-STAT FLOWABLE HEMOSTAT |
| Generic Name | HEMOSTAT |
| Product Code | MHW |
| Date Received | 2014-10-01 |
| Model Number | 4000 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASCULAR SOLUTIONS, INC. |
| Manufacturer Address | 6464 SYCAMORE COURT NORTH MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-10-01 |