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

Model Number M00510880

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191); Insufficient Information (4580)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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 in the common bile duct during an endoscopic mechanical lithotripsy (eml) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the basket failed to crush a stone and the tip failed to detach.An olympus emergency handle was attached to the trapezoid device in an attempt to detached the tip of the basket; however, the pull wire broke at approximately 20 cm from the handle.The procedure was not completed and the scheduled enbd may have been cancelled.The basket was stuck inside the patient and was scheduled to be surgically removed on (b)(6) 2020.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported that a trapezoid rx lithotripter basket was used in the common bile duct during an endoscopic mechanical lithotripsy (eml) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the basket failed to crush a stone and the tip failed to detach.An olympus emergency handle was attached to the trapezoid device in an attempt to detached the tip of the basket; however, the pull wire broke at approximately 20 cm from the handle.The procedure was not completed and the scheduled enbd may have been cancelled.The basket was stuck inside the patient and was scheduled to be surgically removed on (b)(6) 2020.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: device code a0401 captures the reportable event of pull wire break.Device code a150301 captures the reportable event of tip failure to separate.Impact code f19 is being used to capture surgery required to remove the basket from the patient.Block h10: visual analysis found the device was returned disassembled when received.The basket wires were likely cut and the remaining part was not returned.No issues were found in the basket wires and the tip.The external sheath was found torn and buckled.The working length was found kinked.The cannula was returned still attached to the handle assembly.The basket tip joint strength was measured and found within specification.Based on all available information, the force applied to the handle did not reach the tip of the basket most likely due to the friction of the internal components caused by the working length kinked and the sheath torn/buckled at proximal section.The failures of kinks and sheath torn are likely to happen due to incorrect device interaction with other devices or tortuous anatomy of the bile duct, which is beyond the device performance.Likely, the wires were cut by the customer to remove the device from the patient's body and it is not considered as an issue of 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.A labeling review was performed, and there is no evidence of a device misuse from the information provided.The ifu addresses the surgical method on emergency precautions.The ifu cited: "if calculus can not be removed from the basket, follow clinical and/or surgical standards of practice".

• 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: 11046630
• MDR Text Key: 222668970
• Report Number: 3005099803-2020-06320
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2021
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0025719155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention