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

Model Number M00510890

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable investigation finding that the sidecar rx was pushed back.Block h10: the returned trapezoid rx basket was analyzed, and a visual inspection observed the basket was folded and the side car rx was pushed back.Dimensional inspection noted the push back was approximately 3.5 mm, which is out of specification.The customer provided a picture where it was possible to observe the basket was folded.The reported event was confirmed.Based on all available information, it is possible that the manipulation or technique applied during the procedure could have contributed to the adverse event, even causing pushback of the side car rx.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 used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the basket wires were twisted.A photo provided by the customer shows the distal tip of the basket wires were twisted.Another trapezoid rx basket was used to complete the procedure.There were no patient complications as a result of this event.Note: investigation results revealed the sidecar rx was pushed back out of specification; therefore, this is now an mdr reportable 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: 17506382
• MDR Text Key: 321353410
• Report Number: 3005099803-2023-04316
• 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
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0031189382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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