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

Model Number M00510890

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Open or Close (2921); Material Deformation (2976)

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

Event Date 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device problem code a0406 captures the reportable investigation finding of side car rx push back.Block h10: the returned trapezoid rx was analyzed, and a visual inspection observed the sheath was buckled at the proximal section.The side car was found pushed back approximately 3.0 mm which is out of specification.Functional test observed the basket was able to open without problem on the first attempt.The coil was in good condition.The reported event was not confirmed; however, the sheath was found buckled and the side car rx was pushed back.The buckled sheath indicates difficulty when trying to open the basket which caused an excess of tension on the working channel.This excess of tension could have caused the damage to the sheath and side car rx.It is possible that the manipulation of the device, technique used, or patient's anatomical conditions could have contributed to this event.Therefore, the most probable root cause of sheath buckled, and side car rx pushback is adverse event related to procedure.Taking all information into consideration, the most probable root cause of the reported event is no problem detected.

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the basket was unable to open inside the patient.There was not a stone inside the basket when it failed to open.Another trapezoid rx was used to complete the procedure.There were no patient complications as a result of this event.This event has been deemed a reportable event based on the investigation finding of sidecar push back.Please see block h10 for full investigation details.

• 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: 17933927
• MDR Text Key: 325913521
• Report Number: 3005099803-2023-05472
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2023

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: Health Professional
• Device Expiration Date: 10/18/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0030365378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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 Age: 60 YR
• Patient Weight: 50 KG