MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-06 for FLEXIMA CATHETER UNK540 manufactured by Boston Scientific - Costa Rica (coyol).
[104599085]
Age at time of event: (b)(6). (b)(4). Device evaluated by manufacturer: the device was not returned for analysis. The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user: "do not allow alcohol to contact the catheter. Exposing the catheter to alcohol may damage the coating and catheter. " (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[104599086]
It was reported that the catheter was broken and the patient was sent to surgery. The target lesion was located in the liver. A 6 french flexima catheter was selected for use. During the procedure, alcohol was used to treat the tumor through the flexima catheter. However, it was noted that the catheter broke in half. The procedure was then discontinued and the patient underwent surgery to remove the broken component. Subsequently, the fragment was removed successfully and this was confirmed via endoscopy. No further patient complications were reported and the patient's condition was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-02717 |
| MDR Report Key | 7403989 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-06 |
| Date of Report | 2018-03-13 |
| Date of Event | 2018-03-12 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2018-04-06 |
| 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 | 2018-04-06 |
| 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 | 1. Required No Informationntervention | 2018-04-06 |