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

Model Number	M00566491
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	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a endovive safety peg kit push method used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the feeding tube detached as the physician was trying to pull it through the incision site.A second safety peg kit push method; however, same thing happened, the feeding tube detached upon pulling it through the incision site.The procedure was still completed with the second endovive safety peg kit push method.There were no patient complications reported due to this event.
Additional Manufacturer Narrative
(device codes): problem code 2907 captures the reportable event of feeding tube detached.Visual examination of the returned device revealed that the peg tube was in two pieces.The distal tip was detached.The distal tip appeared to be cut.The complaint was consistent with the reported incident that the peg tube was detached/separated.It is likely that operational factors, such as user handling/technique, excessive force, and patient anatomy, contributed to the feeding tube damage.Based on all gathered information, the complaint investigation conclusion code selected is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.A labeling review was performed and no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that a endovive safety peg kit push method used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the feeding tube detached as the physician was trying to pull it through the incision site.A second safety peg kit push method; however, same thing happened, the feeding tube detached upon pulling it through the incision site.The procedure was still completed with the second endovive safety peg kit push method.There were no patient complications reported due to this event.

• Brand Name: ENDOVIVE SAFETY 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: 8112650
• Report Number: 3005099803-2018-61648
• Device Sequence Number: 11195656
• Product Code: KNT
• UDI-Device Identifier: 08714729802655
• UDI-Public: 08714729802655
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/08/2019

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: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: M00566491
• Device Catalogue Number: 57700
• Device Lot Number: 0022654678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/16/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1