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

Model Number M00510890

Device Problems Use of Device Problem (1670); Separation Failure (2547)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

The patients exact age is unknown; however, it was reported that the patient was over 18 years of age.(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 basket was used in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket to perform mechanical lithotripsy.However, the basket failed to crush the stone and the tip of the basket failed to separate leaving the stone stuck inside the basket.The handle was disassembled and the wire was moved in order to release the stone and remove the basket from the patient.The procedure was completed with another trapezoid rx basket.There were no patient complications reported as a result of this event.

Manufacturer Narrative

H10: block a2: the patients exact age is unknown; however, it was reported that the patient was over 18 years of age.Block h6: device code a150301 captures the reportable event of tip failure to separate.Block h10: visual inspection of the returned device found the tip was intact and still attached to the basket assembly.Therefore, the reported event is confirmed.The handle cannula and working length were found kinked/bent.The handle cannula was found pulled out of the finger ring portion of the handle assembly.Both dimples from the screws were visible at proximal section of the handle cannula.Additionally, the thumb ring was detached from the handle.The handle and thumb ring showed coincident marks that indicate proper assembly during manufacturing process.The handle had marks where the thumb ring was located indicating likely a lot of force was applied to the device.Distal and proximal screw depth were measured and found within specification.Functional inspection was performed and found the basket tip joint strength within specification.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device's performance and integrity.Handling and manipulation of the device during its use can result in kinks/bends in the device, this condition would cause friction between the components at kinked/bent areas leading to an improper distribution of the force applied to the handle through the device.Additionally, this could have caused issues to release the tip.Too much force applied to the handle to release the tip can result in handle cannula and thumb ring detachment.Therefore, the most probable root cause is adverse event related to the 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, from the information available, this device was not used per the instructions for use (ifu) / product label as the device was expired when used.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket to perform mechanical lithotripsy.However, the basket failed to crush the stone and the tip of the basket failed to separate leaving the stone stuck inside the basket.The handle was disassembled and the wire was moved in order to release the stone and remove the basket from the patient.The procedure was completed with another trapezoid rx basket.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: 11014057
• MDR Text Key: 222010613
• Report Number: 3005099803-2020-06004
• 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: 02/12/2021

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: 10/15/2020
• 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: 01/05/2021
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1