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

Model Number M00510880

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the biliary duct was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During procedure, the device couldn't go over the wire, and they found the wire channel was too small upon inspection.The procedure was completed with another trapezoid rx.There were no patient complications reported as a result of this event.Investigation results revealed the sidecar push back; therefore, this is now an mdr reportable event (see block h10 for investigation details).

Manufacturer Narrative

Block d4; h4: the complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.Block h6: imdrf device problem code a0406 captures the reportable investigation finding of side car rx push back.H10: the returned trapezoid rx lithotripter basket was received for analysis, and a visual inspection observed that the side car rx had the tip flattened and also was pushed back.A functional test was performed by passing a guidewire through the side car rx and it would not pass due to the tip of the side car rx being flattened.Based on all available information, the reported event was confirmed.The damage found to the side car rx could have been generated due to the technique used during the procedure, excessive manipulation of the device, or the patient's anatomical conditions.Therefore, the most probable root cause is adverse event related to procedure.A ship history review was performed to identify the most probable lots and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.

• 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: 18502655
• MDR Text Key: 333159123
• Report Number: 3005099803-2024-00018
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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