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

Model Number	M00568520
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 (osb) used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the button portion of the one step button tube became stuck in the patient's pharynx and caused a minor hemorrhage which was reported to have stopped by the end of the procedure.There was no treatment administered.In addition, there was strong resistance when pulling out the osb from the stoma site.The procedure was completed with a new endovive one step button.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6 (device codes): problem code 2920 captures the reportable event of one step button difficult to advance.H10: visual analysis of the one endovive replacement button kit revealed that the unit returned did not show evidence of either the alleged issue or any defect that could have contributed to the event reported.No foreign materials, air bubbles, voids were identified indicating the material was formed properly.The dome was released and was not returned for analysis.Therefore the customer complaint was not confirmed.The investigation concluded that, without analysis of the device, there is a lack of objective evidence or descriptive conditions of the event required to determine a probable root cause of 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 instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an endovive one step button (osb) used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the button portion of the one step button tube became stuck in the patient's pharynx and caused a minor hemorrhage which was reported to have stopped by the end of the procedure.There was no treatment administered.In addition, there was strong resistance when pulling out the osb from the stoma site.The procedure was completed with a new endovive one step button.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 10844445
• Report Number: 3005099803-2020-05487
• Device Sequence Number: 3629960
• 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): 12/22/2020

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: 07/06/2023
• Device Model Number: M00568520
• Device Catalogue Number: 6852
• Device Lot Number: 0025983289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1