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

Model Number M00510870

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

Reported event of side car - rx pushback.A visual evaluation of the returned device found the basket wires retracted when received and residue is present on the device indicating use/ handling.Moreover, the side car-rx was found torn at the proximal end and presented pushback out of specification.The handle was actuated, however, the basket wires failed to extend.Further evaluation found the basket wires were cut from the pull wire's cannula.Additionally, the rest of the basket wires and tip were not returned for analysis.The evaluation concluded that during the procedure manipulation of the device and interaction with the scope or other devices most likely contributed to the side car - rx pushback and torn.Therefore, the most probable root cause is operational context, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, performance was limited.The review of the device history record (dhr) was performed and no anomalies were found.A search of the database confirmed 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) 2016.According to the complainant, during the procedure, an alliance handle was used in conjunction with a trapezoid¿ rx basket in an attempt to crush a 1.5 cm stone, however, the basket failed to crush the stone.The tip of the basket was detached to release stone.The procedure was 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 fine.This event has been deemed a reportable event based on the investigation results; side car-rx (guidewire port) pushback.

• 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: 6156913
• MDR Text Key: 61855333
• Report Number: 3005099803-2016-03787
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: (01)08714729296386(17)20170113(10)18807159
• 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: 11/21/2016

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: 01/13/2017
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 18807159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• 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