MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE ONE STEP BUTTON; TUBE, GASTRO-ENTEROSTOMY

Model Number	M00568510
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive onestep button was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2021.Post procedure, the right angle feeding port was obstructed.The device was replaced with a new right angle feeding tube.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a1409 captures the reportable event of feeding port blocked/occluded block h10: a bolus feeding set was returned.Visual analysis revealed that the tube didn't present an unknown substance that could obstruct it.Therefore, the complaint of right angle feeding port obstructed was not confirmed.However, the tube was kinked on where the c-clamp was locked.Based on the condition of the returned device, engineers determined that the failure mode observed could be caused by the locked c-clamp, therefore, this kink created some resistance/difficulties to pass liquid through the tube.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 the event which led to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an endovive onestep button was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2021.Post procedure, the right angle feeding port was obstructed.The device was replaced with a new right angle feeding tube.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE ONE STEP BUTTON
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12121777
• Report Number: 3005099803-2021-03223
• Device Sequence Number: 4777188
• Product Code: KGC
• UDI-Device Identifier: 08714729151081
• UDI-Public: 08714729151081
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K910584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 07/29/2023
• Device Model Number: M00568510
• Device Catalogue Number: 6851
• Device Lot Number: 0025890037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1