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

Model Number M00510870

Device Problems Break (1069); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a 12 mm stone size.However, the distal tip of the trapezoid basket did not release, and the pull wire was broken, entrapping the stone inside the basket and causing the basket to become stuck inside the patient's bile duct.A balloon was used to perform a dilation-assisted stone extraction (dase) and remove the basket with stone from the patient's bile duct.There were no patient complications as a result of this event.The patient's condition post procedure was reported to be stable / good.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a 12mm stone size.However, the distal tip of the trapezoid basket did not release, and the pull wire was broken, entrapping the stone inside the basket and causing the basket to become stuck inside the patient's bile duct.A balloon was used to perform a dilation-assisted stone extraction (dase) and remove the basket with stone from the patient's bile duct.There were no patient complications as a result of this event.The patient's condition post procedure was reported to be stable/good.

Manufacturer Narrative

Block h6: problem code 1069 captures the reportable event of pull wire break.Problem code 2547 captures the reportable event of tip failure to separate.Block h10: visual inspection found the returned device was cut in the proximal section of the coil.The pull wire (basket wire) was removed from the coil and it was found kinked/bent in several locations.The handle cannula was found pulled out of the finger ring portion of the handle assembly.Both dimples from the screws were visible at proximal section of the handle cannula.Drag marks were present from the dimples towards the proximal end, indicating the cannula had been forcibly pulled out from the set screws.The distal screw and proximal screw depth were measured and both were found within specification.The basket did not present any visual damage or abnormalities.The tip is intact and still attached to the basket wire assembly.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device's performance and integrity.Patient anatomy and user maneuvering to reach the intended locations can add more resistance when actuating the handle.Drag marks observed in the handle cannula indicates that a lot of force was applied to the handle to crush the stone or retract the basket, resulting in pull wire bent/kinked, pull wire break, and handle cannula detachment.Detachment of the handle cannula can occur when force is applied perpendicular to the finger ring/handle assembly.Therefore, the most probable root cause is adverse event related to procedure.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.Block h11: correction: block e1 (initial reporter address).

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9396363
• MDR Text Key: 168659646
• Report Number: 3005099803-2019-05831
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2020
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0024335749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1