MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-28 for BALKIN UP AND OVER CONTRALATERAL DESIGN FLEXOR CHECK FLO INTRODUCER REF# G10383 manufactured by Cook, Inc.
[137686034]
Right popliteal and tibioperoneal trunk atherectomy procedure when surgical team noticed, the balkin 6 fr introducer tip looked unusual under fluoroscopy. Introducer withdrawn, noticed wire was advanced past coating. Case continued with new sets of wire. It was determined that there was no missing tip but the internal wire advanced past the coating. Product was returned to vendor for analysis; pending further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084545 |
| MDR Report Key | 8382019 |
| Date Received | 2019-02-28 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-01-29 |
| Date Added to Maude | 2019-03-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALKIN UP AND OVER CONTRALATERAL DESIGN FLEXOR CHECK FLO INTRODUCER |
| Generic Name | INTRODUCER, CATHETER |
| Product Code | DYB |
| Date Received | 2019-02-28 |
| Returned To Mfg | 2019-02-08 |
| Catalog Number | REF# G10383 |
| Lot Number | 8511824 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC |
| Brand Name | ZIPWIRE 260-CM HYDROPHILIC GUIDE WIRE |
| Generic Name | CATHETER, INTRODUCER KIT |
| Product Code | OFC |
| Date Received | 2019-02-28 |
| Returned To Mfg | 2019-02-08 |
| Catalog Number | REF #M00146154B0 |
| Lot Number | 10886778 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-28 |