MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRAPEZOID¿ RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510880

Device Problems Separation Failure (2547); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual analysis of the return device found the thumb ring cracked and has stress marks with a whitened appearance.The tip was found to be properly attached to the basket.The evaluation concluded that the crack and the stress marks with whitened appearance that were found on the thumb ring are evidence that compressive force was applied by the alliance handle.The device is designed so that the basket tip detaches if the stone cannot be crushed.However, it is unknown what tensile force was applied to the device during the attempt to detach the tip.Although it cannot be determined how the tip failed to detach, stone size and density, user technique, tortuous anatomy and other procedural factors could possibly contribute to the failure by causing the tensile force applied by the user to not be fully distributed throughout the device.Therefore, the most probable cause is ¿operational context¿, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure the performance of the product was limited.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

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) 2017.According to the complainant, during procedure, an alliance handle was used in conjunction with a trapezoid¿ rx basket in an attempt to crush a black gallstone.However, the basket failed to crush the stone.While trying to crush the stone the handle almost broke and part turned white, and the tip of the basket did not detach.The physician was able to open the basket and remove the stone from the trapezoid¿ rx basket device.The procedure was successfully 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 good.

• Brand Name: TRAPEZOID¿ RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7101935
• MDR Text Key: 95073804
• Report Number: 3005099803-2017-03721
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2017

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: 08/28/2018
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 21061634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1