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

Catalog Number M00509020

Patient Problem Insufficient Information (4580)

Event Date 03/08/2024

Event Type  malfunction  

Event Description

The snare in the peg kit was defective and did not work correctly.The snare that comes in the peg kit (ref #m00509020, lot #32558008) was defective.The plastic sheath was completely broken, preventing the snare to be deployed appropriately.Items in question bagged and will be returned to materials.(b)(4), the vendor for boston scientific was contacted.Information about the product was shared with him, we are now waiting for further instructions.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18922028
• MDR Text Key: 338148186
• Report Number: MW5152916
• Device Sequence Number: 1
• Product Code: PIF
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M00509020
• Device Lot Number: 32558008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White