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

Model Number	M00563040
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
This report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2018-00992 for the first endovive¿ one step button¿ 3005099803-2018-00993 for the second endovive¿ one step button¿.It was reported to boston scientific corporation that an endovive one step button was used during a peg replacement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the physician tried to grasp the peg tube from the stomach to pull it through but the tube kept breaking.A second one step button gastrostomy kit was used; however, it happened again.Reportedly, alligator forceps were used.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.

• Brand Name: ENDOVIVE¿ ONE STEP BUTTON¿
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7389452
• Report Number: 3005099803-2018-00993
• Device Sequence Number: 1314910
• Product Code: KGC
• UDI-Device Identifier: 08714729268833
• UDI-Public: 08714729268833
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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: 08/31/2019
• Device Model Number: M00563040
• Device Catalogue Number: 6304
• Device Lot Number: 21435158
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR