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

Model Number	M00568211
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	05/01/2020
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure (b)(6) 2020.According to the complainant, during the procedure, when the physician was placing the peg tube, it pulled apart.The procedure was completed with a new endovive standard peg kit push method.There were no patient complications reported as a result of this event.

• 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: 10075322
• Report Number: 3005099803-2020-01992
• Device Sequence Number: 14165110
• Product Code: KNT
• UDI-Device Identifier: 08714729285205
• UDI-Public: 08714729285205
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2021
• Device Model Number: M00568211
• Device Catalogue Number: 6821
• Device Lot Number: 0024446328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1