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

Model Number M00510890

Device Problems Break (1069); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

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

Event Date 02/27/2022

Event Type  malfunction  

Manufacturer Narrative

The patient's exact age is unknown; however, it was reported that the patient was over 18 years of age.(b)(4).The returned trapezoid rx was analyzed, and a visual evaluation observed that the thumb ring was detached.The thumb ring has traces of junction with the handle.The device was returned without a sheath and side car.Based on all available information, it is possible that the missing side car led to the reported event of guidewire difficult to advance.It was reported that the problem was observed during preparation; however, it was found that the thumb ring was detached so it is possible that the device could have faced excess manipulation.Perhaps the technique used could have contributed to the reported event.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During preparation, the basket was opened and found the guidewire was unable to advance through the side car.A different basket was used to complete the procedure.No patient complications have been reported as a result of this event.The investigation results revealed the thumb ring was detached; therefore, this is now an mdr reportable event.Please see 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: 15584571
• MDR Text Key: 306689917
• Report Number: 3005099803-2022-05974
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 10/11/2022

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: 08/02/2022
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0027763448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• 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 Sex: Male