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	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(evaluation conclusion codes): 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 was used during a percutaneous endoscopic gastrostomy (peg) placement procedure (b)(6) 2020.According to the complainant, during the procedure, the one step button sheath detached when the physician was pulling it through the stoma site.Reportedly, the button portion was able to be grasped before it fell into the patient's stomach.The procedure was completed with this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code 2907 captures the reportable event of one step button detached.Block h10: a visual examination of the device revealed that only one portion of the delivery system (connector, heat shrink and one portion of the tubing) was returned for analysis.It was found the tubing detached near to the connector.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.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 available this device was used per the directions for use (dfu).
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, the one step button sheath detached when the physician was pulling it through the stoma site.Reportedly, the button portion was able to be grasped before it feel into the patient's stomach.The procedure was completed with this device.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: 10310923
• Report Number: 3005099803-2020-02921
• Device Sequence Number: 3384653
• 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): 08/25/2020

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: 06/26/2022
• Device Model Number: M00568520
• Device Catalogue Number: 6852
• Device Lot Number: 0024089621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1