MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	M00509011
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Advance (2920)
Health Effect - Clinical Codes	Perforation (2001); No Code Available (3191)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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
It was reported to boston scientific corporation that a endovive safety peg kit pull method used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2020.According to the complainant, during the procedure, the peg tube was difficult to pull through the stoma.The physician introduced the trocar however an initial incision was not done first.Reportedly, problems began when incisions were made alongside the tubing while trying to pull the tube through the site.This created several micro perforations.The patient went to surgery.Per physician assessment, the peg tube contribute to the micro perforations.The ifu (instructions for use) endovive safety peg kit pull method fourth step states the following: using the exposed blade of the safety scalpel provided, make a 1 to 1.5 cm incision at the selected incision site.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10777112
• Report Number: 3005099803-2020-05020
• Device Sequence Number: 11673960
• Product Code: PIF
• UDI-Device Identifier: 08714729880417
• UDI-Public: 08714729880417
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150679
• 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): 11/03/2020

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 Model Number: M00509011
• Device Catalogue Number: 57707
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/03/2020
• 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