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

Model Number M00510890

Device Problem Separation Failure (2547)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, an alliance handle ii was used in conjunction with the trapezoid basket to crush a stone.However, after many attempts, the basket failed to break the stone and the tip failed to detach.With the stone still inside the basket, the physician shook the basket until the stone was released.The basket was pulled out and another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has been received for analysis.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a150301 captures the reportable event of tip failure to separate.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the thumb ring was cracked, the sheath was buckled, the working length was kinked and the basket was kinked.The distal tip of the basket was still attached.Under microscope magnification, remnants of use were noted and the distal end of the side car rx was smashed.A dimensional inspection noted that the side car rx was pushed back approximately 5.0mm, which is out of specification.No other issues with the device were noted.The reported event was confirmed.Based on all available information, it is possible that due to the manipulation or technique used at the time to interact with the device in conjunction with the tortuousness or patient's anatomy, may have caused complications in the procedure that led to the device not working as planned.The basket wires kinking may have caused an incorrect distribution of force applied at the time of trying to break the stone, so the functionality of the device was affected and the tip did not separate.Additionally, working length kink, sheath buckled and side car rx push back are evidence that indicate over manipulation.The thumb ring break is a consequence of extra force being applied.Therefore, the most probable root cause for the problem reported and problems found during the investigation is adverse event related to procedure.A device history record (dhr) 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 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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, an alliance handle ii was used in conjunction with the trapezoid basket to crush a stone.However, after many attempts, the basket failed to break the stone and the tip failed to detach.With the stone still inside the basket, the physician shook the basket until the stone was released.The basket was pulled out and another trapezoid rx basket was used to complete the procedure.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
• 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: 14017345
• MDR Text Key: 288663294
• Report Number: 3005099803-2022-01709
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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 Model Number: M00510890
• Device Catalogue Number: 1089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 04/29/2022
• 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