MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE JEJUNAL FEEDING TUBE; TUBE, FEEDING

Model Number	M00566340
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(initial reporter facility name): (b)(6).(b)(4).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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive jejunal feeding tube was placed during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the jejunal tube has an occlusion.The procedure was completed with a new endovive jejunal feeding tube.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1 (initial reporter facility name): (b)(6).Block e1 (initial reporter address): (b)(6).Block h6 (device codes): problem code 2423 captures the reportable event of jejunal tube obstruction.Block h6 (evaluation conclusion codes): 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive jejunal feeding tube was placed during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the jejunal tube has an occlusion.The procedure was completed with a new endovive jejunal feeding tube.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on april 6, 2020: there was a sharp angulation at the distal end of the probe, which prevented the passage of the guidewire.
Additional Manufacturer Narrative
Additional information: b5, e1 (initial reporter address, city and zip/post code).Block e1 (initial reporter facility name): (b)(6).Block e1 (initial reporter address): (b)(6).Block h6 (device codes): problem code 2423 captures the reportable event of jejunal tube obstruction.Block h10: during product analysis it was observed that one endovive jejunal feeding tube was returned (flexible stiffing cannula, guidewire and jejunal tube).No visual issues were identified with the flexible stiffing cannula.The guidewire was kinked/bent at distal section.The jejunal tube had a severe kinked at distal section.During functional inspection the returned flexible stiffing cannula and guide wire could not be advanced through the jejunal tube due to severe kinking at distal section.It is most likely the jejunal tube and guidewire could have kinked due to procedural or anatomical factors encountered during procedure.Once the device is severely kinked the lumen of the tube would be reduced causing issues to advance the guidewire.Probably the guidewire was damaged as result of attempts to pass the guide wire through the kinked area of the tube.Based on the information available and the analysis performed, the investigation conclusion code for the complaint will be documented as known inherent risk of device due to the reported adverse event known and documented in the labeling including both short or long term known complications or adverse reactions.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available this device was used per the directions for use (dfu).
Event or Problem Description
It was reported to boston scientific corporation that an endovive jejunal feeding tube was placed during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the jejunal tube has an occlusion.The procedure was completed with a new endovive jejunal feeding tube.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on april 6, 2020.There was a sharp angulation at the distal end of the probe, which prevented the passage of the guidewire.

• Brand Name: ENDOVIVE JEJUNAL FEEDING TUBE
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9898487
• Report Number: 3005099803-2020-01392
• Device Sequence Number: 2238356
• Product Code: KNT
• UDI-Device Identifier: 08714729789666
• UDI-Public: 08714729789666
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2020

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 Expiration Date: 01/02/2021
• Device Model Number: M00566340
• Device Catalogue Number: 6634
• Device Lot Number: 0023133531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/06/2020; 09/24/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/16/2020; 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR