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

Model Number	M00568510
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual analysis of the device revealed that one step button delivery system was broken into two pieces and stretched.It is most likely that procedural factors encountered during procedure could have affected the device performance and its integrity.Probably the tubing was detached due to user technique, patient anatomy or other procedural factors.As per visual analysis, the delivery system was broken, some additional force applied during the procedure while trying to release the dome or when they tried to insert the unit into the patient could cause the device to stretched and it broke.Based on the information available and the analysis performed, it was determined that the investigation conclusion code for the complaint will be documented as adverse event related to procedure since the event occurred during the preparation and the device had no influence on the event.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 provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/dfu.
Event or Problem Description
It was reported to boston scientific corporation that an endovive one step button was used in a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device was defective.The procedure was completed with a new endovive one step button.There were no patient complications reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.This event has been deemed a reportable event based on the investigation results: one step button delivery system was broken into two pieces and stretched.

• 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: 10513625
• Report Number: 3005099803-2020-03805
• Device Sequence Number: 3538710
• Product Code: KGC
• UDI-Device Identifier: 08714729151081
• UDI-Public: 08714729151081
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K910584
• 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
• Report Date (Section B): 09/10/2020

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: 04/30/2020
• Device Model Number: M00568510
• Device Catalogue Number: 6851
• Device Lot Number: 0020745701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1