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

Model Number M00510890

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/09/2021

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 basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.According to the complaint, during the procedure, a trapezoid basket was used in an attempt to crush a 2-2.5 cm stone size.However, the pull wire of the trapezoid basket was detached during the attempt, leaving the stone stuck inside the basket.The physician opened the basket into a larger size to let the stone fall and the basket was simply pulled out from the common bile duct.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.According to the complaint, during the procedure, a trapezoid basket was used in an attempt to crush a 2-2.5 cm stone size.However, the pull wire of the trapezoid basket was detached during the attempt, leaving the stone stuck inside the basket.The physician opened the basket into a larger size to let the stone fall and the basket was simply pulled out from the common bile duct.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device problem code a0501 captures the reportable event of pull wire break.Block h10: visual analysis of the returned device found the handle was likely cut from the working length.Also, the cannula was found severely kink, broken, and was likely cut.The coil was found unraveled; however, no issues were found on the tip and it was still attached.Additionally, the external sheath was found torn and buckled, the working length was found kinked, and the side car rx tunnel was found torn and pushed back out of specification.The dimples were visible on the handle cannula and were properly located.Drag marks were present from the proximal and distal screw toward the proximal end as the cannula has been forcibly pulled out from the set screws which were found to be present in the handle assembly.The distal 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 could cause severe kinking in the working length.This would also lead to the handle cannula detaching from the handle.Drag marks observed indicate that force was applied to the handle when retracting the basket.The excessive force applied when they tried to retract the basket could lead to the sheath torn/buckled condition.The marks in the side car rx tunnel are consistent with the ones caused when the guidewire is pulled out through the side car wall once the guidewire is in place.Also, the customer likely cut the handle cannula in order to remove the device from the scope and this could cause the coil condition.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.

• 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: 11240263
• MDR Text Key: 229031512
• Report Number: 3005099803-2021-00262
• 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: 03/04/2021

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: 06/23/2021
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0025632101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 01/10/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 56