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 2019-05-21 for COPE MANDRIL WIRE GUIDE N/A PMG-18SP-60-COPE manufactured by Cook Inc.
[145650136]
Occupation: clinical specialist. Pma/510(k) #: preamendment. (b)(4). 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
[145650137]
It was reported a cope mandril wire guide was used in a (b)(6) male patient for a peripheral angiogram. The user reports that this was not the wire from the micropuncture kit, as it was opened separately. The report states that the user had radial access in the left arm, with an aortogram and imaging completed through the arm. A runoff of both legs through that approach was done and access to the groin was attempted. The micropuncture wire was advanced through the needle, the needle was removed and the micropuncture dilator was inserted. As the user attempted to remove the micropuncture wire with the dilator, the wire pulled apart (elongated) and separated on the way out. As reported, approximately 100 mm of the wire, including the distal tip, remained in the patient. However, due to the patients heavily calcified femoral artery, they could not gain access for a snare to attempt to retrieve the remaining wire fragment. The patient was scheduled for an open bypass endarterectomy (date unknown) therefore, the user decided to delay removal until then. No other adverse effects were reported for this incident. No resistance was encountered as the wire was removed through the micropuncture sheath with the dilator. There was no kinking of the wire noted. It was reported that there may have been some sort of manipulation of the wire while inside the needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00989 |
| MDR Report Key | 8628128 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-21 |
| Date of Report | 2019-06-24 |
| Date of Event | 2019-05-09 |
| Date Mfgr Received | 2019-06-17 |
| Device Manufacturer Date | 2019-03-07 |
| Date Added to Maude | 2019-05-21 |
| 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 | 2019-05-21 |
| Returned To Mfg | 2019-06-04 |
| Model Number | N/A |
| Catalog Number | PMG-18SP-60-COPE |
| Lot Number | 9513360 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2019-05-21 |