MAUDE Adverse Event Report: BOSTON SCIENTIFIC SPHINCTEROME

Model Number GTN08714729778264

Device Problem Defective Device (2588)

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

Event Date 04/26/2016

Event Type  Injury  

Event Description

During ercp procedure, the sphincterotome was advanced through the scope.While in use it was noted to be defective.It was removed and replaced with another one.

• Brand Name: SPHINCTEROME
• Type of Device: SPHINCTEROME
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; MA 01752
• MDR Report Key: 5885371
• MDR Text Key: 52514797
• Report Number: MW5064154
• Device Sequence Number: 1
• Product Code: KNS
• 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: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GTN08714729778264
• Device Catalogue Number: M00584040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 103