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

Model Number M00510880

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem Perforation (2001)

Event Date 06/30/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the bile duct during a bile duct stone extraction procedure performed on (b)(6) 2022.During the procedure, a trapezoid rx basket was attempted to be used to crush a stone roughly 1.5 - 2cm in size.However, the basket could not close, leaving the stone stuck inside basket.The pull wire was broken.A wire cutter was used in an attempt to separate the working length from the handle so they could use a soehendra device, but was unsuccessful.With the stone still stuck inside the basket, the whole scope was pulled out with the basket inside the patient causing perforation in the distal duct.The procedure was not completed.The patient was sent to interventional radiology for percutaneous transhepatic cholangiography (ptc) with fully covered 10x60 biliary metal stent placed and internal/external drain put in.The patient was rescheduled for another procedure to have additional stones removed.

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h6: device code a0401captures the reported event of pull wire break.Block h10: the returned trapezoid basket was analyzed, and a visual evaluation noted that the device was returned with the sheath cut off from the handle.The handle cannula was detached and has drag marks of the fastening screws.The side car rx was pushed back out of specification.The internal wires, and the sheath were found kinked.No other issues were noted.The reported event of pull wire broken was not confirmed.Based on all available information, it is likely that the physician interpreted the investigation finding handle cannula detached as pull wire break.The drag marks from the fastening screws found on the handle cannula indicates that excess force may have been applied.It is possible that the functionality of the device could have been affected by the technique used, patient's tortuosity, or anatomical conditions.The returned device does not allow a functional test to establish the cause of the reported failure to close.It was also reported that it was necessary to cut the working length, and the use of an additional device.The investigation finding side car rx pushback, sheath kinked, and wire kinked could have occurred as a consequence of manipulation when cutting the working length.The adverse event "perforation" is listed in the instructions for use (ifu) as "perforation by catheter tip" and is known as a possible complication, inherent risk of the device.The root cause of the reported impact codes cannot be determined with device analysis.The cause code of the investigation findings handle cannula detached/separated, side car rx pushback, sheath kinked, and wire kinked 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.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: block h6 impact codes and device code has been corrected.

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the bile duct during a bile duct stone extraction procedure performed on (b)(6) 2022.During the procedure, a trapezoid rx basket was attempted to be used to crush a stone roughly 1.5 - 2cm in size.However, the basket could not close, leaving the stone stuck inside basket.The pull wire was broken.A wire cutter was used in an attempt to separate the working length from the handle so they could use a soehendra device, but was unsuccessful.With the stone still stuck inside the basket, the whole scope was pulled out with the basket inside the patient causing perforation in the distal duct.The procedure was not completed.The patient was sent to interventional radiology for percutaneous transhepatic cholangiography (ptc) with fully covered 10x60 biliary metal stent placed and internal/external drain put in.The patient was rescheduled for another procedure to have additional stones removed.

• 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: 15094481
• MDR Text Key: 296494461
• Report Number: 3005099803-2022-03968
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/08/2022

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: 05/18/2023
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0029422767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• 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 Outcome(s): Required Intervention