MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-03-13 for ENDOVIVE? JEJUNAL FEEDING TUBE M00566340 6634 manufactured by Boston Scientific - Costa Rica (coyol).
[102320141]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. (b)(4). The device has been received for analysis. Upon 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.
Patient Sequence No: 1, Text Type: N, H10
[102320142]
It was reported to boston scientific corporation that an endovive three-port through the peg jejunal tube was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2018. According to the complainant, after placement was performed, tube blockage occurred frequently due to kink, and the kink issue was resolved using a biopsy forceps through endoscope. Recurrence of issue within a week was noticed. The procedure was completed with a new endovive three-port through the peg jejunal tube. There were no patient complications reported due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-00767 |
| MDR Report Key | 7335969 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-03-13 |
| Date of Report | 2018-02-26 |
| Date of Event | 2018-02-23 |
| Date Mfgr Received | 2018-03-25 |
| Date Added to Maude | 2018-03-13 |
| 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. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| 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 | ENDOVIVE? JEJUNAL FEEDING TUBE |
| Generic Name | TUBE, FEEDING |
| Product Code | FPD |
| Date Received | 2018-03-13 |
| Returned To Mfg | 2018-03-05 |
| Model Number | M00566340 |
| Catalog Number | 6634 |
| 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 | 2018-03-13 |