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

Model Number M00510870

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual analysis of the returned device found the basket was retracted, the basket tip was intact, and the side car-rx was torn at the distal end of the device.The handle cannula have been pulled out of the finger ring portion of the handle assembly and had been pushed forward into the distal end of the handle assembly.Drag marks were present indicating that the cannula was forcibly pulled out from the set screws.The evaluation concluded that during the procedure excessive manipulation of the device and interaction with the scope or other devices most likely contributed to the side car-rx torn and handle cannula detached.Probably due to excessive force applied to the handle, the handle cannula was pulled out of the finger ring portion.Therefore, the most probable root cause of this complaint is ¿operational context¿, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, performance was limited.A review of the device history record (dhr) was performed and no anomalies were noted.

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the distal end of the sheath was torn.The procedure was completed with another trapezoid¿ rx basket.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 ¿fine¿.This event has been deemed an mdr-reportable event based on investigation results which revealed that the handle cannula detached.

• 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: 7139246
• MDR Text Key: 95923989
• Report Number: 3005099803-2017-03761
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2017

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: 08/07/2018
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 20977961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2017
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2017
• 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