MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH ENDOVIVE¿ SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M00566490
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
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
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2018-01138 for the first endovive¿ safety peg push kit and 3005099803-2018-01139 for the second endovive¿ safety peg push kit.It was reported to boston scientific corporation that endovive¿ safety peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the physician was tracking the peg tube over the guidewire, the peg tube detached at the transition zone between the hard and soft plastic inside the patient.A second endovive¿ safety peg kit push method was used; however, the peg tube also detached.The detached portion was retrieved using a snare.The procedure was completed with a new endovive safety peg kit push method.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: ENDOVIVE¿ SAFETY PEG KIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7406908
• Report Number: 3005099803-2018-01139
• Device Sequence Number: 1030299
• Product Code: KNT
• UDI-Device Identifier: 08714729748410
• UDI-Public: 08714729748410
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K031538
• 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): 03/19/2018

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: 04/30/2019
• Device Model Number: M00566490
• Device Catalogue Number: 6649
• Device Lot Number: 21592508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/09/2018
• 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