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

Model Number M00510880

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).Visual evaluation of the returned device found the basket was in a closed position when received.The side car-rx presented pushback out of specification.Functional evaluation showed the basket would not open.The black heat shrink was removed and found that the coil was detached from the distal end of the handle.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 pushback and coil detach.Furthermore, coil detach from the handle affects the ability of the device to open and close in a clinical setting.Therefore, the most probable root cause of this complaint is operational context, since due to anatomical and/or procedural factors encountered during the procedure, performance was limited.

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx basket was used in the choledoc during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the basket would not open.There was no stone inside the basket when it failed to open.Additionally, friction was felt on the handle's level; however, there were no visible damage noted on the handle.The procedure was completed with another trapezoid 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 "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 - 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: 7118032
• MDR Text Key: 95747445
• Report Number: 3005099803-2017-03570
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 11/19/2017

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 Model Number: M00510880
• Device Catalogue Number: 1088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2017
• Initial Date FDA Received: 12/14/2017
• 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