MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-23 for COPE MANDRIL WIRE GUIDE N/A PMG-18SP-60-COPE manufactured by Cook Inc.
[145903923]
Product code: dqx. Initial reporter also sent report to fda: unknown. Pma/510(k) #: pre-amendment. 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
[145903924]
It was reported a cope mandril wire guide was used for a cardiac catheterization procedure. Upon being withdrawn through the needle, the wire unraveled. As stated by the user, "after discussion with ir, the surgeons, and the other cath docs, decision made to continue pulling and unravel the wire, leaving just the platinum tip in the patient". No other adverse events or additional procedures were reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01181 |
| MDR Report Key | 8635495 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-23 |
| Date of Report | 2019-08-05 |
| Date Mfgr Received | 2019-07-31 |
| Date Added to Maude | 2019-05-23 |
| 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 | 2019-05-23 |
| Model Number | N/A |
| Catalog Number | PMG-18SP-60-COPE |
| 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 | 2019-05-23 |