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

Model Number M00510890

Device Problem Separation Failure (2547)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2019.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket to crush a stone.However, the basket failed to crush the stone.Furthermore, the tip of the basket failed to detach to release the stone.The basket with the stone was finally removed by forcibly pulling the basket but caused bleeding.The bleeding was stopped by a metal stent, and the procedure was completed at this time.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; ,; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; ,; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8730885
• MDR Text Key: 149078424
• Report Number: 3005099803-2019-03252
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2020
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0023445083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention