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 2018-06-12 for FLEXIMA? M001271860 27-186 manufactured by Boston Scientific - Costa Rica (coyol).
[110807335]
(b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[110807336]
It was reported that the catheter became fractured and a fragment remained inside patient's body. A flexima? Drainage catheter was selected for use during nephrostomy under fluoroscopy guidance. During the procedure, the device kinked in several segments of the microguide. Consequently, upon removal, the device became fractured with a fragment of the device left in the lower renal pelvis. The procedure was stopped and re-scheduled as there was no other device available. No further patient complications reported and the patient's condition was stable.
Patient Sequence No: 1, Text Type: D, B5
[120863858]
Device evaluated by mfr: the guidewire component was returned for analysis and damage was observed as part of overall visual revision. The drainage catheter was not returned for analysis. The coil was found unraveled at the distal section. Additionally, the core wire was broken. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[120863859]
It was reported that the catheter became fractured and a fragment remained inside patient's body. A flexima? Drainage catheter was selected for use during nephrostomy under fluoroscopy guidance. During the procedure, the device kinked in several segments of the microguide. Consequently, upon removal, the device became fractured with a fragment of the device left in the lower renal pelvis. The procedure was stopped and re-scheduled as there was no other device available. No further patient complications reported and the patient's condition was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-05342 |
| MDR Report Key | 7593227 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-12 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-05-20 |
| Date Mfgr Received | 2018-08-31 |
| Device Manufacturer Date | 2016-12-16 |
| Date Added to Maude | 2018-06-12 |
| 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? |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2018-06-12 |
| Returned To Mfg | 2018-06-15 |
| Model Number | M001271860 |
| Catalog Number | 27-186 |
| Lot Number | 20058153 |
| Device Expiration Date | 2019-12-09 |
| 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 | 2018-06-12 |