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

Model Number M00510880

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 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned trapezoid rx basket was analyzed, and a visual evaluation noted that the side car rx tunnel was pushed back and torn.Functional inspectional was performed and found the basket was able to open and close properly.No issues were noted on the handle or the working length.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 employed 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 of the side car was pushed back.Therefore, the most probable root cause is adverse event related to the procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, the basket failed to retract back into the sheath.Another trapezoid 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 mdv reportable event.

Manufacturer Narrative

Block h2: block h10 updated with labeling review.Block h6: device problem code a0406 captures the reportable investigation result of side car rx push back.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the side car rx tunnel was pushed back and torn.Functional inspectional was performed and found the basket was able to open and close properly.No issues were noted on the handle or the working length.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 employed 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 of the side car was pushed back.Therefore, the most probable root cause is adverse event related to the procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, the basket failed to retract back into the sheath.Another trapezoid 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 mdv 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: 13119084
• MDR Text Key: 285619610
• Report Number: 3005099803-2021-08030
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 10/06/2022

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: 06/09/2022
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0027462696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• 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