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

Model Number M00510890

Device Problems Difficult to Open or Close (2921); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/04/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During the procedure, when the handle was pulled, the basket failed to open, and the sidecar rx pushed back.There were no known patient complications as a result of this event.

Manufacturer Narrative

Block e1: initial reporter address: yangsan univ, bumea-ri, mulkeum-eup.Block h6: imdrf device code a0406 captures the reportable event of sidecar rx pushback.

Manufacturer Narrative

Block e1: initial reporter address: yangsan univ, bumea-ri, mulkeum-eup block h6: imdrf device code a0406 captures the reportable event of side car rx push back block h10: visual inspection of the returned device found that the side car rx was torn and buckled.A dimensional test was performed and confirmed that the side car rx was pushed back approximately 3 mm, which is out of specification.Additionally, a functional test was performed by attempting to open the basket, however the basket was unable to open successfully.Lastly, a destructive test noted that the pull wire was detached, and the sheath was buckled.No other issues were noted.The reported event was confirmed.Based on all available information, the basket could not be fully deployed due to the pull wire's detachment from the handle.The pull wire detachment could've been caused by excessive force being applied to the handle; the buckled sheath provided evidence that the physician was manipulating the device with more force than required.The side car rx was also affected as excessive force generated may cause extra stress on the working length, causing the side car to push back, ultimately making it impossible to open the basket fully.Therefore, the most probable root cause for reported event is "adverse event related to procedure".

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, when the handle was pulled, the basket failed to open, and the sidecar rx pushed back.There were no known patient complications 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: 17825650
• MDR Text Key: 324368473
• Report Number: 3005099803-2023-05096
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0031891886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1