MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-11-19 for COPE MANDRIL WIRE GUIDE N/A PMG-18SP-60-COPE manufactured by Cook Inc.
[166998470]
Concomitant medical products: 21 gauge needle. Occupation: lead tech. Pma/510(k) #: preamendment. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[166998471]
It was reported that an unknown patient required the placement of a cope mandril wire guide for a left leg venogram procedure. While gaining access in the popliteal vein, the operator reported "the wire tip broke off outside of the vein in the surrounding tissue. " during removal of the device, the operator "felt a snap of the wire. " the operator "cut down into the patients tissue" with hemostats to remove the "broken" wire, requiring the patient to have stitches placed. Another new, similar device was used to successfully complete the procedure. No other adverse effects were reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-02921 |
| MDR Report Key | 9340818 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-11-19 |
| Date of Report | 2019-11-19 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2019-11-11 |
| Device Manufacturer Date | 2019-09-26 |
| Date Added to Maude | 2019-11-19 |
| 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 | MR. LARRY POOL |
| 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 | 2019-11-19 |
| Model Number | N/A |
| Catalog Number | PMG-18SP-60-COPE |
| Lot Number | 9999246 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-11-19 |