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

Model Number M00510890

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 lithotripter basket was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the biliary tract on (b)(6) 2020.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 handle cannula broke and the basket was left open inside the patient.The stone was released from the basket and the physician pulled the basket several times until the basket was removed from the patient.The patient was rescheduled for another ercp for additional stone fragmentation.A photo submitted by the customer confirmed the handle cannula was broken.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: device code 1069 captures the reportable event of handle cannula break.Problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: visual inspection of the returned device found the handle cannula was detached from the handle and was totally moved out inside of the coil.No issues were found in the basket wires and the tip was still attached to the basket wires assembly.The working length had some kinks.The unit was disassembled, and dimples were visible on the handle cannula and were properly located.Drag marks were present from the proximal and distal screw towards the proximal end as the cannula has been forcibly pulled out from the set screws.Additionally, a kink was found in the distal section.During the evaluation, the handle label was removed exposing the set screws which were found to be present in the handle assembly.The distal screw and proximal screw depth were measured, and both were found within specification.The sidecar rx tunnel was found pushed back out of specification and was torn.Based on all available information, the investigation concluded that that procedural factors encountered during the procedure could have affected the device performance and its integrity.Handling and manipulation of the device during use could lead to the handle cannula pulling out from the handle.Drag marks observed in the handle cannula indicate that force was applied to the handle to retract the basket, resulting in the handle cannula detachment and the reported failure.Marks observed in the sidecar rx tunnel is consistent with the ones caused when the guidewire is pulled out through the tunnel.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 lithotripter basket was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the biliary tract on (b)(6) 2020.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 handle cannula broke and the basket was left open inside the patient.The stone was released from the basket and the physician pulled the basket several times until the basket was removed from the patient.The patient was rescheduled for another ercp for additional stone fragmentation.A photo submitted by the customer confirmed the handle cannula was broken.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 10350847
• MDR Text Key: 201550991
• Report Number: 3005099803-2020-03026
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2020
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0024604617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1