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 2016-10-11 for MALECOT M001224110 22-411 manufactured by Boston Scientific - Costa Rica (coyol).
[57052324]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[57052325]
It was reported a catheter fracture occurred. During the nephrostomy change of a malecot drainage catheter placed in the kidney, the tube fragmented upon removal. The remainder of the tube was able to extracted. No further patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[61410432]
Device evaluated by manufacturer: a visual examination identified a foreign material attach, as part of overall visual revision. The catheter is blackened in different locations, broken and it is bent in several locations. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable root cause was unable to be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[61410433]
It was reported a catheter fracture occurred. During the nephrostomy change of a malecot drainage catheter placed in the kidney, the tube fragmented upon removal. The remainder of the tube was able to extracted. No further patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2016-08919 |
| MDR Report Key | 6018417 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-11 |
| Date of Report | 2016-09-13 |
| Date Mfgr Received | 2016-11-07 |
| Date Added to Maude | 2016-10-11 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| 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 | MALECOT |
| Generic Name | CATHETER, PERITONEAL |
| Product Code | GBW |
| Date Received | 2016-10-11 |
| Returned To Mfg | 2016-09-29 |
| Model Number | M001224110 |
| Catalog Number | 22-411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-10-11 |