MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) TRAPEZOID¿ RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510880

Device Problems Separation Failure (2547); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual analysis of the returned device found the working length (sheath, coil assembly and the pull wire) was cut at its proximal section.The distal section of the pull wire including the basket and the basket tip was not returned.Additionally, the thumb ring was found deformed.The evaluation confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The device was designed for calculus larger than 15 mm.However, the stone involved was smaller and the force applied could have been insufficient to detach the tip.Therefore, the most probable root cause is ¿user/use error¿.It is possible that the deformed thumb ring could have been caused by the alliance device since this product applies tension/force to this specific section of the trapezoid during stone removal.Therefore, the most probable cause is "operational context".The device history record (dhr) review found that the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.Labeling review was performed and found the dfu instructions were not followed since the product was used with the intention of crush a stone smaller (12 mm) than as it was designed for (calculus larger than 15 mm).

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx basket was used in the common bile duct during a lithotripsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket to crush a 12 mm stone.However, the stone could not be crushed and the tip failed to detach.Additionally, the handle was damaged.The handle was cut and the scope was removed.Another scope was inserted and electrohydraulic lithotripsy (ehl) was performed to remove the stone.The procedure was completed with another trapezoid¿ rx basket.There were no patient complications reported as a result of this event.

• Brand Name: TRAPEZOID¿ RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7712053
• MDR Text Key: 114803694
• Report Number: 3005099803-2018-02313
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2018

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 Model Number: M00510880
• Device Catalogue Number: 1088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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