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

Lot Number 28103006

Device Problems Defective Component (2292); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2022

Event Type  malfunction  

Event Description

During placement, the peg tube kit had a trochar in it that was defective, the tip was blunt.Another peg kit was opened and the trochar in that kit was also defective.There were also issues with the snares in both kits.The tips of the snares were bent/kinked so provider was unable to put the snare into the scope.Another peg tube kit, a push, was opened so the trochar and snare could be used for the procedure.When the gi tech was obtaining another peg tube kit, nurse was trying to assist provider with the snare, it was during this time that needle placement was lost.The provider was able to use a new trochar from the push kit.The procedure was completed, and an abdominal binder put on patient to protect the peg.Patient was doing well and returned to his room.Fda safety report id # (b)(4).

• Brand Name: ENDOVIVE SAFETY PEG KIT - PULL.
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES).
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION.
• MDR Report Key: 13770482
• MDR Text Key: 287428860
• Report Number: MW5108153
• Device Sequence Number: 2
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 28103006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White