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 2018-06-04 for FLEXIMA? M001271560 27-156 manufactured by Boston Scientific - Costa Rica (coyol).
[110008045]
(b)(4). Device evaluated by manufacturer: the device was returned for analysis. Visual inspection identified that the flexible cannula was received loaded inside the catheter. Additional, the proximal section of flexible cannula (hub) was not returned. Residues were noted between the flexible cannula and the stent at the distal section. Functional inspection was performed and observed that the flexible cannula could not be remove from the catheter, the catheter was accordioned in distal section while the flexible cannula was pulled back. Therefore, a transversal cut was perform at catheter tip, the tip cannula was not found stuck inside the tip step. After the cut, excessive force was used to removed the flexible cannula and it removed properly. Dimensional inspection of the stent catheter length and tip step were performed and were within specifications. Also, dimensional inspection of the outer diameter of the flexima cannula (proximal section, middle section, distal section) were performed and were within specification. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. 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. As per product dfu: "operational instructions prior to placement prior to use, all devices to be used for the procedure should be carefully examined to verify the sterile barrier, proper function, and integrity". (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[110008046]
Reportable based on device analysis completed on 10-may-2018. It was reported that the device used was expired and difficulty removal of the stiffener occurred. An expired flexima? Was selected for use. During procedure, after the catheter was advanced, the stiffener was then removed. However, upon removing the stiffener, the catheter got stretched really bad and started to fray. The tubing was then cut and an amplatz wire was placed over the tube, put it around the stiffener and pulled out the stiffener. The stiffener was then removed without harming the patient. The procedure was completed with a different device. No patient complications were reported and the patient was fine. However, device analysis revealed that there were residues noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-05089 |
| MDR Report Key | 7567141 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-04 |
| Date of Report | 2018-05-10 |
| Date of Event | 2017-12-04 |
| Date Mfgr Received | 2018-05-10 |
| Device Manufacturer Date | 2014-10-21 |
| Date Added to Maude | 2018-06-04 |
| 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 | 2018-06-04 |
| Returned To Mfg | 2018-03-27 |
| Model Number | M001271560 |
| Catalog Number | 27-156 |
| Lot Number | 17374627 |
| Device Expiration Date | 2017-10-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-06-04 |