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 Code Available (3191)

Event Date 09/24/2020

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 basket was used during a common bile duct lithiasis procedure performed on (b)(6) 2020.According to the complainant, during the procedure, there was difficulty capturing the stone with the basket.Once the 10-12mm size stone was captured, the basket could not extract the stone and the basket remained in the common bile duct.Additionally, the handle cannula broke during an attempt to crush the stone with an alliance handle.Stent placement was performed to allow upstream drainage.The procedure was not completed.Patient was scheduled for surgery to remove the basket and gall bladder on an unknown date.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be good.

Manufacturer Narrative

Block h6: patient code 3191 captures the additional intervention of a second procedure.Device code 1069 captures the reportable event of handle cannula break.Device code 3191 is being used to capture the reportable issue of procedure aborted/cancelled.Block h10: visual inspection of the returned device found the basket-wire assembly was completely removed from the device.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.Drag marks were present from dimples towards the proximal end as the cannula had been forcibly pulled out from the set screws.The handle cannula, pull wire and working length were kinked/bent.The basket was not present and it was observed that the basket section is completely burnt.Working length and pull wire were cut, marks observed on the components indicate that a mechanical tool was likely used to cut the device.The distal screw and proximal screw depth were measured and found within specification.Based on all available information, it is most likely that procedural or anatomical factors encountered during procedure could have affected the device's performance and integrity.Handling and manipulation of the device could have led to kinks/bends in the device.This condition would cause friction between the components at the kinked/bent areas and led to difficulty in opening/closing the basket.Continued attempts to extend/retract the basket can result in handle cannula detachment from the finger ring.Drag marks were noted in the handle cannula which indicates that a lot of force was applied to the handle resulting in a handle cannula detachment.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 that the device was used not in accordance with the labeling.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used during a common bile duct lithiasis procedure performed on (b)(6) 2020.According to the complainant, during the procedure, there was difficulty capturing the stone with the basket.Once the 10-12mm size stone was captured, the basket could not extract the stone and the basket remained in the common bile duct.Additionally, the handle cannula broke during an attempt to crush the stone with an alliance handle.Stent placement was performed to allow upstream drainage.The procedure was not completed.Patient was scheduled for surgery to remove the basket and gall bladder on an unknown date.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be good.

• 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: 10813064
• MDR Text Key: 215476970
• Report Number: 3005099803-2020-05086
• 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: 01/26/2021

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: 10/16/2020
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0024611670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR