MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-24 for UNIVERSAL STENT-FIRM 6X26 G23406 manufactured by Cook Medical.
[24550780]
Universal stent-firm 6x26, while under fluoroscopy (no scope), the monofilament wire broke while within the patient. Wire had to be pulled and removed in four different pieces as it continued to unravel. Case time was increased by 10 minutes during this process of searching and removing the pieces from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055802 |
| MDR Report Key | 5038573 |
| Date Received | 2015-08-24 |
| Date of Report | 2015-08-24 |
| Date of Event | 2015-08-20 |
| Date Added to Maude | 2015-08-28 |
| 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 | 0 |
| Brand Name | UNIVERSAL STENT-FIRM 6X26 |
| Generic Name | UNIVERSAL STENT-FIRM 6X26 |
| Product Code | FEW |
| Date Received | 2015-08-24 |
| Model Number | G23406 |
| Lot Number | 5942162 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | BLOOMINGTON IN 47402 US 47402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-24 |