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

Model Number M00510890

Device Problems Defective Device (2588); Material Deformation (2976)

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

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.(b)(4).The returned trapezoid rx basket was analyzed, and a visual inspection noted that the side car rx was pushed back.The working length was free of kinks.The basket didn't present any visual issues.The handle was actuated and the basket was able to open and close without issues.A dimensional inspection was performed and the exposed metal was measured and had 1.5mm of exposed metal, which is out of specification.No other issues were noted.The reported event was not confirmed.Based on all available information, side car rx pushed back could be related to user manipulation while inserting/removing the guidewire and/or some technique applied while opening the basket that may have caused a tough movement within the coil and sheath.Therefore, the most probable root cause is adverse event related to procedure.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during an endoscopic biliary stone removal procedure performed on (b)(6) 2021.During preparation, the basket was found deformed.A non-bsc device was used to complete the procedure.There were no patient complications reported as a result of this event.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; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12960672
• MDR Text Key: 281918255
• Report Number: 3005099803-2021-06334
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/08/2021

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 Model Number: M00510890
• Device Catalogue Number: 1089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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