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

Model Number M00510890

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the dealer.The physician present for this case was: dr.(b)(6) at (b)(6) hospital in (b)(6).Initial reporter address: (b)(6).(b)(4).The returned trapezoid rx basket was analyzed, and a visual analysis found the side car rx was pushed back out of specification.The working length was free of obvious kinks.A functional inspection found the basket would open and close without issues, and the guide wire could be inserted and withdrawn from the side car rx without problems.Dimensional inspection confirmed the issue of side car rx push back as the exposed metal was measured at 5.0mm, which is out of specification.No other issues were noted.Based on all available information, the side car rx push back may be related to user manipulation and/or some technique applied during procedure.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During procedure, the basket was inserted into the common bile duct along the guide wire.However, the guidewire could not be removed from the trapezoid basket while inside the patient's anatomy.Another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.Investigation results revealed that the side car-rx tunnel was pushed back out of specification; therefore, this is now an mdr reportable event.Please see 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: 12651370
• MDR Text Key: 278645411
• Report Number: 3005099803-2021-05328
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2021

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: 09/02/2021
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0025959539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• 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: 63 YR
• Patient Weight: 77