MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-09-17 for FLEXOR CHECK FLO INTRODUCER G11638 manufactured by Cook Incorporated.
[2975583]
Patient had left heart cath, received 6f 55 cm sheath. Upon sheath exchange over the wire, as the sheath pulled back over the wire, the sheath sheared and a piece separated from the sheath structure. Physician accessed the right brachial artery, passed a snare to the aorta, snared a piece of sheath and pulled back to brachial artery. Another physician then performed a cutdown to retrieve the sheath. Two hours s/p left heart cath the patient developed expressive aphasia. Initial ct was negative for chair. Subsequent mri showed multifocal bilateral cvas.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2752241 |
| MDR Report Key | 2752241 |
| Report Source | 99 |
| Date Received | 2012-09-17 |
| Date of Report | 2012-09-17 |
| Date of Event | 2012-09-07 |
| Date Facility Aware | 2012-09-07 |
| Report Date | 2012-09-17 |
| Date Reported to FDA | 2012-09-17 |
| Date Reported to Mfgr | 2012-09-17 |
| Date Added to Maude | 2012-09-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXOR CHECK FLO INTRODUCER |
| Generic Name | 6F 55CM RAABE SHEATH (OEX) |
| Product Code | OEX |
| Date Received | 2012-09-17 |
| Model Number | G11638 |
| Lot Number | 3094640 |
| Device Expiration Date | 2015-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-17 |