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

Model Number M00510880

Device Problem Break (1069)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888)

Event Date 08/27/2020

Event Type  malfunction  

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 choledoco during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket to attempt to crush a stone.When the basket closed to extract the stone, the handle cannula broke causing the basket to become stuck inside the patient.The physician began to perform maneuvers to release the stone and remove the cable, however, the physician had to use force, and this led to a mild mucosal injury around the papilla causing it to bleed.The physician used a balloon to generate hemostasis.Additionally, the wire bruised the physician's hand, but no treatment was done.Another trapezoid rx basket was used to complete the procedure.

Event Description

It was reported that a trapezoid rx lithotripter basket was used in the choledoco during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket to attempt to crush a stone.When the basket closed to extract the stone, the handle cannula broke causing the basket to become stuck inside the patient.The physician began to perform maneuvers to release the stone and remove the cable; however, the physician had to use force and this led to a mild mucosal injury around the papilla causing it to bleed.The physician used a balloon to generate hemostasis.Additionally, the wire bruised the physician's hand but no treatment was done.Another trapezoid rx basket was used to complete the procedure.

Manufacturer Narrative

Block h6: device code 1069 captures the reportable event of handle cannula break.Block h10: visual analysis 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 handle cannula had been forcibly pulled out from the set screws.The handle cannula, pull wire and working length were found kinked/bent.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 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 the kinked/bent areas causing difficulty to open/close the basket.Continued attempts to extend/retract it can result in handle cannula detachment from the finger ring.Drag marks observed in the handle cannula indicate that a lot of force was applied to the handle, which could have contributed to the 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, from the information available, this device was used per the instructions for use (ifu) product label.The instructions for use (ifu) does not address the issue of "bruise & handle cannula break".However, the instructions for use (ifu) mentions "bleeding" as a possible complication and it noted within the adverse events section of the ifu.Also instructions for use (ifu) contains the steps needed for a correct use of the device.

• 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: 10569723
• MDR Text Key: 208124646
• Report Number: 3005099803-2020-04003
• 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: 01/08/2021

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: 12/17/2020
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0024951684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1