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

Model Number M00566490

Device Problems Material Puncture/Hole (1504); Difficult to Open or Close (2921); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2022

Event Type  malfunction  

Event Description

Endovive safety peg kit snare contained in kit was very tight and did not open and close as expected.Soft plastic sheath below rigid plastic sheath was observed to be twisted with a hole noted in the proximal soft plastic sheath.Fda safety report id# (b)(4).

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13711230
• MDR Text Key: 287000739
• Report Number: MW5107968
• Device Sequence Number: 1
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/07/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: M00566490
• Device Catalogue Number: M00566490
• Device Lot Number: 28699644
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White