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

Model Number	M00568520
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The device has been received for analysis.Upon 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 one step button initial placement gastrostomy kit was used during a gastrostomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the tube separated while it was being pulled out.Since the stomach wall was fixed, the button part was retrieved using a snare and was pulled out.The procedure was completed with a different device (non bsc device).There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an endovive one step button initial placement gastrostomy kit was used during a gastrostomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the tube separated while it was being pulled out.Since the stomach wall was fixed, the button part was retrieved using a snare and was pulled out.The procedure was completed with a different device (non bsc device).There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(initial reporter facility name): (b)(6) hospital.(device codes): problem code 2907 captures the reportable event of feeding tube detached.Visual examination of the returned device revealed that the one step button was broken approximately at 14cm from the button dome and it was irregular.The complaint was consistent with the reported incident that the one step button was broken.It is most likely that procedural and anatomical factors encountered during the procedure could have affected the device performance and its integrity.Probably the one step catheter was broken due to user technique, patient anatomy or other procedural factors such the incision size, also a lot of force applied to pull the device during placement could have contributed with the event.Based on the information available and the analysis performed, the investigation conclusion code for the complaint 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 dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.

• 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: 8473216
• Report Number: 3005099803-2019-01529
• Device Sequence Number: 1474490
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: M00568520
• Device Catalogue Number: 6852
• Device Lot Number: 0022904797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other