MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID; LITHOTRIPTER, BILIARY MECHANICAL

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/25/2016

Event Type  malfunction  

Event Description

During endoscopic retrograde cholangiopancreatography (ercp) the biliary tree was swept with a trapezoid basket starting at the bifurcation.Sludge was swept from the duct.All stones were removed.While closing the trapezoid basket to crush the stones, a give away was felt.Under fluoroscopy the metallic cap of the trapezoid basket was noted to be in the bile duct, as the balloon was reinserted to remove the fragment, it was noted to migrate upstream and into a branch of a left intrahepatic duct.Multiple attempts to selectively cannulate the left intrahepatic duct failed.

• Brand Name: TRAPEZOID
• Type of Device: LITHOTRIPTER, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6036383
• MDR Text Key: 57717269
• Report Number: 6036383
• Device Sequence Number: 1
• Product Code: LQC
• 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: Patient
• Type of Report: Initial
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Other Device ID Number: 19369744
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR