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

Model Number M00510870

Device Problems Separation Failure (2547); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance handle was being used in conjunction with the basket in an attempt to release a 0.5 cm stone, but the basket tip would not deploy.After two hours of manipulation using hurricane and extractor pro balloons, the stone fell out of the basket.The basket was removed through the scope.The procedure was then cancelled and scheduled for a later date.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, an alliance handle was being used in conjunction with the basket in an attempt to release a 0.5 cm stone, but the basket tip would not deploy.After two hours of manipulation using hurricane and extractor pro balloons, the stone fell out of the basket.The basket was removed through the scope.The procedure was then cancelled and scheduled for a later date.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device code 2547 captures the reportable event of tip failure to separate.Problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned trapezoid rx was analyzed, and a visual evaluation noted that only the basket wire assembly was returned for analysis.It was completely removed from the coil assembly.It was found kinked/bent in several locations in the basket wire.Additionally, drag marks were present on the handle cannula from dimples towards the proximal end as the cannula had been forcibly pulled out from the set screws.The basket did not present any visual damages or abnormalities.The basket tip was intact and it was still attached to the basket assembly.A functional evaluation was not performed due to the device condition.It is possible that anatomical or procedural factors encountered during the procedure, such as manipulation of the device during its use or the device encountering too much force, could have resulted in pulling out the handle cannula from the handle and kinking the pull wire.Therefore, the most probable root cause for the failures found during analysis is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 10135120
• MDR Text Key: 194550706
• Report Number: 3005099803-2020-02198
• 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: 07/15/2020

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: 10/28/2020
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0024674035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention