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

Model Number M00510870

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a trapezoid rx basket was used in an attempt to crush a stone.However, the stone could not be crushed and the tip of the basket failed to detached.No patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a trapezoid rx basket was used in an attempt to crush a stone.However, the stone could not be crushed and the tip of the basket failed to detached.No patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: device code 2547 captures the reportable event of tip failure to separate.Block h10: visual inspection of the returned device found the handle cannula was detached from the handle.No issues were found in the basket wires and the tip was still intact.The handle cannula was inspected, dimples were visible on the handle cannula and properly located.Drag marks were present from the proximal and distal screw towards the proximal end as the cannula has been forcibly pulled out from the set screws.The distal screw and proximal screw depth were measured and both were found within specification.Based on all available information, the investigation concluded that procedural and anatomical factors encountered during the procedure likely affected the device's performance and integrity.Handling and manipulation of the device and interaction with another device can lead to the handle cannula pulling out from the handle.The drag marks in the handle cannula indicates that excessive force was applied to the handle to crush the stone resulting in 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.

• 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: 9709338
• MDR Text Key: 190361217
• Report Number: 3005099803-2020-00392
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

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: 10/03/2020
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0024543461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1