MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for MICROPUNCTURE INTRODUCER SET G47950 manufactured by Cook Inc..
[134700746]
Malfunctioning left brachial artery to basilic vein av fistula. Taken to operating room (b)(6) 2019 for lue diagnostic fistulogram with peripheral venous angioplasty. Noted during procedure, had sudden while movements of his left arm and indwelling micro needle shared the micro guidewire. At this time anesthesia was deepened, a small 1 centimeter incision was made and the guidewire fragment was extracted in its entirety.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083454 |
| MDR Report Key | 8286565 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-25 |
| Date of Event | 2019-01-17 |
| Date Added to Maude | 2019-01-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MICROPUNCTURE INTRODUCER SET |
| Generic Name | INTRODUCER CATHETER |
| Product Code | OFC |
| Date Received | 2019-01-28 |
| Returned To Mfg | 2019-01-17 |
| Catalog Number | G47950 |
| Lot Number | 9347693 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-28 |