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

Model Number M00566090

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2020

Event Type  malfunction  

Event Description

Upon attempted activation of the retrieval snare in the endovive safety peg kit, there was a snapping sound and the snare would not open.Plastic covering by the catheter / wire junction was discovered to be broken.Fda safety report id# (b)(4).

• Brand Name: ENDOVIVE SAFETY PEG KIT - RETRIEVAL SNARE
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; marlborough MA 01752
• MDR Report Key: 9817929
• MDR Text Key: 183291078
• Report Number: MW5093652
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: M00566090
• Device Lot Number: 24994563
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR