MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for FLEXIMA manufactured by Boston Scientific Corporation.
[183109486]
Percutaneous cholecystostomy tube placed without difficulty. Was broken at seam of the flexible portion with the stiff portion outside of the patient. The interventional radiologist felt that this was likely a manufacturing defect because the break was very smooth. The catheter did not appear crushed by the patient rolling on it or by any other trauma. The catheter was exchanged quickly and easily the following day. The failed catheter was sequestered by the manager to be sent back to the manufacturer. No patient harm noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9823651 |
| MDR Report Key | 9823651 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-18 |
| Report Date | 2020-03-02 |
| Date Reported to FDA | 2020-03-02 |
| Date Reported to Mfgr | 2020-03-12 |
| Date Added to Maude | 2020-03-12 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIMA |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2020-03-12 |
| Lot Number | 23914972 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |