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

Model Number M00510890

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A visual evaluation of the returned device found the basket closed and the tip was intact.Residues were present on the device indicating use and handling.Additionally, the side car - rx presents pushback out of specification.The unit was tested inside and outside the endoscope and the basket would open and close without issue.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.Due to anatomical and/or procedural factors encountered during the procedure, performance was limited.Moreover, residues were present on the device indicating use and handling.Therefore, the most probable root cause of this complaint is operational context.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 bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the trapezoid¿ rx basket failed to open.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 stable.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: 6176233
• MDR Text Key: 62435458
• Report Number: 3005099803-2016-03788
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: (01)08714729296409(17)20170610(10)19358627
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 11/24/2016

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: 06/10/2017
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 19358627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2016
• 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