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

Model Number M00510890

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual evaluation of the returned device found the basket wires retracted and un-deformed.The side car-rx presented push back out of specification.Further evaluation found that the thumb ring was detached, deformed and cracked.The tip was detached and not returned for evaluation.The evaluation concluded that most likely an alliance handle was used during the procedure.The alliance handle applies compressive force as evidenced by the deformed and cracked thumb ring.During use, the thumb ring receives only tensile and/ or compressive force(s) applied parallel to the length of the device.Detachment of the thumb ring from the handle assembly occurs when force is applied perpendicular to the thumb ring/ handle assembly, forcing the thumb ring out of the handle assembly.Additionally, the failure side car-rx pushed back out of specification is an issue that could have been generated by excessive manipulation of the device by the user, the interaction with the scope or the interacting with other devices.Therefore, the most probable root cause of this complaint is operational context, since it is most likely 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.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 on (b)(6) 2016.However, no information regarding the circumstances surrounding this event have been able to be obtained.Should additional relevant details become available, a supplemental report will be submitted.This event has been deemed a reportable event based on the investigation results; thumb ring cracked/broken and side car-rx 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: 6190895
• MDR Text Key: 62916591
• Report Number: 3005099803-2016-04031
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: (01)08714729296409(17)20170120(10)18831842
• 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: 12/06/2016

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: 01/20/2017
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 18831842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1