MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-02 for FLEXIMA CATHETER UNK540 manufactured by Boston Scientific - Costa Rica (coyol).
[113002025]
(b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[113002026]
It was reported that it was difficult to remove the catheter. A flexima ureteral stent was being placed in the kidney. During the procedure, it was difficult to retrieve the catheter before the sutures were cut. It was noted the sutures seem to have moved from near the hub to half way down the catheter making it difficult.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-06295 |
| MDR Report Key | 7657095 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-02 |
| Date of Report | 2018-06-07 |
| Date Mfgr Received | 2018-06-07 |
| Date Added to Maude | 2018-07-02 |
| 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 | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIMA CATHETER |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2018-07-02 |
| Model Number | UNK540 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-02 |