MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2002-12-28 for DUETT PRO SEALING DEVICE 2010 0255 manufactured by Vascular Solutions, Inc..
[307221]
The duett pro was deployed following an interventional procedure via a 6 fr sheath in the right common femoral artery. Following the deployment, the pt experienced a cold, pale leg and an arterial occlusion was confirmed. Treatment consisted of thrombolytic and anticoagulation therapies. The treatment was successful and no further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134812-2002-00349 |
| MDR Report Key | 435964 |
| Report Source | 05,07 |
| Date Received | 2002-12-28 |
| Date of Report | 2002-12-23 |
| Date of Event | 2002-11-20 |
| Date Mfgr Received | 2002-12-17 |
| Date Added to Maude | 2003-01-07 |
| 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 | AMANDA JOHNSON, ASSOCIATE |
| Manufacturer Street | 2495 XENIUM LANE N. |
| Manufacturer City | MINNEAPOLIS MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7636564300 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUETT PRO SEALING DEVICE |
| Generic Name | VASCULAR HEMOSTASIS DEVICE |
| Product Code | MHW |
| Date Received | 2002-12-28 |
| Model Number | 2010 |
| Catalog Number | 0255 |
| Lot Number | UNK |
| ID Number | * |
| 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 | 424885 |
| Manufacturer | VASCULAR SOLUTIONS, INC. |
| Manufacturer Address | 2495 XENIUM LANE N MINNEAPOLIS MN 55441 US |
| Baseline Brand Name | VASCULAR SOLUTIONS DUETT PRO SEALING DEVICE |
| Baseline Generic Name | VASCULAR SEALING DEVICE |
| Baseline Model No | 2010 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-12-28 |