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

Lot Number 2607492 20FR

Device Problem Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2020

Event Type  malfunction  

Event Description

During peg placement procedure when pulling tube through abdomen, the tube separated at the junction between the peg tube and the introducer tube at the skin level.Ultimately, successful placement of an endoscopically removable peg with 1 t-fastener.

Event Description

During peg placement procedure when pulling tube through abdomen, the tube separated at the junction between the peg tube and the introducer tube at the skin level.Ultimately, successful placement of an endoscopically removable peg with 1 t-fastener.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11473127
• MDR Text Key: 239484956
• Report Number: 11473127
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2607492 20FR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26645 DA