MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ENDOVIVE¿ JEJUNAL FEEDING TUBE; TUBE, FEEDING

Model Number	M00566340
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Visual evaluation of the returned device found that the tube had been kinked at 43cm from the distal end.The investigation was consistent with the reported event that the device was kinked.Based on the examination of the returned device, the event description and evaluation of other devices with the same issue of feeding tube kinked, the most probable root cause is anticipated procedural complication.
Event or Problem Description
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.

• Brand Name: ENDOVIVE¿ JEJUNAL FEEDING TUBE
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7335969
• Report Number: 3005099803-2018-00767
• Device Sequence Number: 19016455
• Product Code: FPD
• UDI-Device Identifier: 08714729789666
• UDI-Public: 08714729789666
• Combination Product (Y/N): N
• PMA/510(K) Number: K091340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00566340
• Device Catalogue Number: 6634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 03/25/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1