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

Model Number	M00568520
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(initial reporter address): (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 one step button was used during a percutaneous endoscopic gastrostomy (peg) placement procedure (b)(6) 2020.According to the complainant, during the procedure, when one step button was being pulled the tubing separated inside the patient's mouth.The procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1 (initial reporter address): 1-2-18 higashinaebo, higashi-ku, sapporo block h6 (device codes): problem code 2907 captures the reportable event of one step button detached.H10: visual analysis of the one step button assembly revealed that the unit returned shows that the button was not released, the dilating tip detached from the tubing.Therefore, the reported complaint was confirmed.In addition, the c-flex tubing is narrowed near distal end indicating stretching of material due to tensile force.The outer diameter of the c-flex tubing was measured in some points of the device, the outer diameter was found out of specification in a narrow section confirming that the component was stretched.It is most likely that procedural and anatomical factors encountered during the procedure could have affected the device performance and its integrity.Probably the c-flex tubing was separated due to user technique, patient anatomy or other procedural factors such the incision size, also force applied to pull the device during placement could have contributed with the event, stretching material on the c-flex tubing suggests that the component was submitted to tensile force during its use.Based on the information available and the analysis performed, the investigation conclusion code for the reported event will be documented as "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on 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 one step button was used during a percutaneous endoscopic gastrostomy (peg) placement procedure (b)(6), 2020.According to the complainant, during the procedure, when one step button was being pulled the tubing separated inside the patient's mouth.The procedure was completed with a new endovive one step button.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: 10904632
• Report Number: 3005099803-2020-05696
• Device Sequence Number: 2709180
• Product Code: KGC
• UDI-Device Identifier: 08714729149231
• UDI-Public: 08714729149231
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910584
• 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): 01/06/2021

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: 08/24/2023
• Device Model Number: M00568520
• Device Catalogue Number: 6852
• Device Lot Number: 0026002027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1