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

Model Number M00510880

Device Problems Difficult to Advance (2920); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was to be used in a procedure performed on november 7, 2023.During the procedure, when the catheter was being advanced over the guidewire, there was some resistance felt during insertion into the papilla.Upon removal, it was observed that the tip of the side car had been torn and pushed back, making it impossible to enter the papilla.Another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

H6: imdrf device code a0406 captures the reportable event of sidecar push back.

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of sidecar push back.Block h10: the returned trapezoid rx basket was analyzed, and a visual inspection observed that the side car rx was torn and pushed back.A dimensional test was performed and confirmed that the side car rx was pushed back 2.5 mm, which is out of specification.No other issues were noted.Based on all available information, the analysis revealed that the side car rx had been pushed back and torn.These issues often result from the technique used during the procedure or excessive force applied, particularly when encountering resistance.Therefore, the most probable root cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was to be used in a procedure performed on (b)(6) 2023.During the procedure, when the catheter was being advanced over the guidewire, there was some resistance felt during insertion into the papilla.Upon removal, it was observed that the tip of the side car had been torn and pushed back, making it impossible to enter the papilla.Another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this 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: 18237450
• MDR Text Key: 329371370
• Report Number: 3005099803-2023-06406
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2023

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 Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0032009965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• 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