MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-03 for COPE MANDRIL WIRE GUIDE N/A PMG-18SP-60-COPE manufactured by Cook Inc.
[168798023]
Pma/510 (k) #: pre-amendment. (b)(4). Concomitant medical products: argon medical- v stick introducer, catheter lot number: 11262629. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[168798024]
It was reported a (b)(6) year-old male patient required a cope mandril wire guide during a procedure for placement of a temporary hemodialysis catheter. The operator reported during attempted access of the right common femoral vein, "the tip to a 0. 018 inch of the guidewire broke off within the extravascular soft tissue of the right upper thigh. " several attempts were performed to remove the fragment wire but were unsuccessful. General surgery was consulted and the patient had the wire fragment successfully removed in the operating room after obtaining a pelvic ct. Temporary hemodialysis catheter was placed on the left side and patient was able to receive the required hemodialysis. No other adverse effects were reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-03000 |
| MDR Report Key | 9401281 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-09-10 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-08-07 |
| Date Added to Maude | 2019-12-03 |
| 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 | 3 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPE MANDRIL WIRE GUIDE |
| Generic Name | DQX WIRE, GUIDE, CATHETER |
| Product Code | DXQ |
| Date Received | 2019-12-03 |
| Model Number | N/A |
| Catalog Number | PMG-18SP-60-COPE |
| Lot Number | 9871922 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-12-03 |