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

Catalog Number M00566090

Device Problems Bent (1059); Difficult to Advance (2920); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 02/06/2018

Event Type  malfunction  

Event Description

Dr.(b)(6) the snare in and opened the snare.It opened just fine but after bringing it around the wire, they were unable to get the snare closed.The guidewire itself was hard to feed through the scope.After they watched it go out the tip of the scope, they noticed the tip was bent.

• Brand Name: ENDODIVE SAFETY PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7295860
• MDR Text Key: 100940066
• Report Number: 7295860
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2018

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: Physician
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: M00566090
• Device Lot Number: 21363912
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 83 YR