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

Model Number M00510890

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

User facility reference number is 3000010000-2019-8022.(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 handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, the alliance handle broke during the attempt and the tip of the basket failed to detach, entrapping the stone inside the basket and causing the basket to become stuck inside the patient's bile duct.A soehendra lithotripter handle was then attached to the wire of the basket to crush the remaining stones and complete the procedure.The procedure was extended by one hour.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block g3: user facility reference number is (b)(4).Block h6: problem code 2547 captures the reportable event of tip failure to separate.Block h10: visual inspection of the returned device found that the basket was extended and the tip was still attached to the basket-wire assembly indicating the tip failed to separate.The rx side car portion of the device was pushed back (out of specification) and was torn in the distal section.The working length was also bent.The proximal section of the device was cut (near the handle).The cut section was inspected under magnification and marks observed on the area indicate that it was intentionally cut.Based on all available information, it is likely that procedural and anatomical factors affected the device's performance and integrity.Also, handling and manipulation of the device during the procedure and interaction with additional devices could have caused the observed damage to the device.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.

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 handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, the alliance handle broke during the attempt and the tip of the basket failed to detach, entrapping the stone inside the basket and causing the basket to become stuck inside the patient's bile duct.A soehendra lithotripter handle was then attached to the wire of the basket to crush the remaining stones and complete the procedure.The procedure was extended by one hour.There were no patient complications reported as a result of this event.

• 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: 9536175
• MDR Text Key: 190340295
• Report Number: 3005099803-2019-06346
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

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: 10/16/2020
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0024611670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR