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 2018-04-10 for FLEXIMA? M001271790 27-179 manufactured by Boston Scientific - Costa Rica (coyol).
[104850608]
Event date: (b)(4) 2018. (b)(4). Device evaluated by mfr: the device was not returned for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[104850609]
It was reported that the suture was broken. The target lesion was located in the mildly tortuous and non calcified torso. A flexima? Was selected for use. During procedure, outside the patient's body, it was noted that the suture broke. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-02766 |
| MDR Report Key | 7410680 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-10 |
| Date of Report | 2018-03-16 |
| Date Mfgr Received | 2018-03-16 |
| Device Manufacturer Date | 2016-10-24 |
| Date Added to Maude | 2018-04-10 |
| 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 | 2018-04-10 |
| Model Number | M001271790 |
| Catalog Number | 27-179 |
| Lot Number | 0019809979 |
| Device Expiration Date | 2019-10-07 |
| 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 | 2018-04-10 |