MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE STANDARD PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M00568200
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had peg, endovive 20 fr, placed and reported approximately 4 months afterward to physician that the peg broke.The patient brought the peg to physician.The inner balloon stopper is gone, presumably 'broken off' inside stomach.The patient had a new peg placed and no harm came to the patient as a result of this event.The device was saved to be returned to the manufacturer.Manufacturer response for tubes, gastrointestinal (and accessories), endovive standard peg kit (per site reporter).The device will be returned for failure analysis.

• Brand Name: ENDOVIVE STANDARD PEG KIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8309750
• Report Number: 8309750
• Device Sequence Number: 2197682
• Product Code: KNT
• UDI-Device Identifier: 08714729748687
• UDI-Public: (01)08714729748687
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2019
• Report Date (Section F): 02/01/2019

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: No Information
• Device Model Number: M00568200
• Device Lot Number: 22202036
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 02/06/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 84
• Date Report Sent to FDA: 02/01/2019