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 03/07/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, a trapezoid rx basket was unpacked, however, it was noted that the four wires at the end of the basket were twisted together and could not be deployed normally, and after several attempts, still to no avail.The procedure was completed with another trapezoid rx basket.There were no patient complications as a result of this event.The investigation results revealed that the side car-rx was pushed back; therefore, this is now an mdr reportable event.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable investigation finding of side car rx pushback.Block h10: the returned trapezoid basket was analyzed, and a dimensional inspection noted that the side car rx was pushed back approximately 7.0mm, which is out of specifications.In addition, the wires at the end of the returned basket were in good conditions.The reported event was not confirmed.Based on all available information, the wires of the basket were not twisted and did not have any damage, therefore, cause code no problem detected was added.The investigation also concluded that the side car rx push back could have occurred due to procedural factors such as the device advancing though the scope that had led to this event.Therefore, cause code adverse event related to procedure was added.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 17131741
• MDR Text Key: 317844099
• Report Number: 3005099803-2023-02933
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0029839706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 41 KG