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); Material Split, Cut or Torn (4008)

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

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The returned trapezoid rx basket was analyzed, and a visual inspection noted that the side car rx was pushed back.The thumb ring was observed to be cracked.The sheath was found torn and buckled.The handle was actuated and the basket was able to open and close without issues.The reported event was not confirmed.Based on all available information, it is possible that the tortuousness to which the device may have been subjected in conjunction with the manipulation and technique may have caused resistance at the time of activating the device.Therefore, an excess of force was applied against the unit, and this would result in loss of its functionality.The conclusion is supported with the evidence of the state in which the unit has returned, the thumb ring was cracked, the sheath was torn and buckled, plus the side car was pushed back.Therefore, the most probable root cause of the failures found during analysis is adverse event related to procedure.However, the investigation observed the basket was able to open and close without issues.Therefore, the root cause for the reported failure is no problem detected.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 procedure performed on (b)(6) 2021.During procedure, the basket failed to close completely.Another trapezoid basket was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure is reported to be stable.Investigation results revealed the side car rx was pushed back; 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: 13119053
• MDR Text Key: 286459762
• Report Number: 3005099803-2021-08038
• 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,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2021

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: 04/22/2022
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0027190201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 67 KG