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

Model Number	M00566340
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an endovive jejunal feeding tube was used during a percutaneous endoscopic gastrostomy procedure on (b)(6) 2022.During the procedure, once the jejunal tube was in place it was tested, a leak was noted in the tubing.The procedure was completed with a new jejunal tube.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H6 (device codes): imdrf device code a0504 captures the reportable event of feeding tube leak inside patient.H10: one endovive jejunal feeding tube was returned.Visual analysis of the device revealed that the tube has a tear in the proximal section on the devices.In addition, a flush test was performed by injecting water, and a leak was found in the proximal section of the devices.Microscopic inspection shows a tear in the tube with more detail.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to the procedural factors that caused the analyzed failure, such as any kind of sharp surface or even a sharp object that could puncture the device integrity and consequently contribute to the leak in the port j-tubes.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.
Event or Problem Description
It was reported to boston scientific corporation that an endovive jejunal feeding tube was used during a percutaneous endoscopic gastrostomy procedure on (b)(6) 2022.During the procedure, once the jejunal tube was in place it was tested, a leak was noted in the tubing.The procedure was completed with a new jejunal tube.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE JEJUNAL FEEDING TUBE
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16139419
• Report Number: 3005099803-2023-00043
• Device Sequence Number: 17771339
• Product Code: KNT
• UDI-Device Identifier: 08714729789666
• UDI-Public: 08714729789666
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K091340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: 08/07/2024
• Device Model Number: M00566340
• Device Catalogue Number: 6634
• Device Lot Number: 0029912762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female