MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00545560
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure, performed on (b)(6) 2021.During the procedure, when the physician attempted to deploy the stent, the wire snagged and the stent deployed prematurely.There were no information on how the procedure was completed.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.This event has been deemed a reportable event based on the investigation finding of guide catheter detached/separated.
Additional Manufacturer Narrative
(b)(4).The returned flexima rx biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached with the stent loaded on it.The pull wire was not broken.Additionally it was observed that the push catheter was kinked and it was torn.No other issues with the device were noted.The reported event was not confirmed.According to the product conclusion, it is most likely that user manipulation, some technique applied while inserting the device and/or even tortuous anatomy could have contributed on kinking the push catheter, once the push catheter was kinked the user may have experienced difficulties on releasing the stent which took the user to apply some technique and/or extra force that ended detaching the guide catheter and tearing part of the push catheter, as result of this issue the user perceived that the stent had a premature deployment.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.Since the pullwire was not found broken, it was not possible to confirm the reported complaint, this code will be assigned as no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13005560
• Report Number: 3005099803-2021-06341
• Device Sequence Number: 4926011
• Product Code: FGE
• UDI-Device Identifier: 08714729337867
• UDI-Public: 08714729337867
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: M00545560
• Device Catalogue Number: 4556
• Device Lot Number: 0025372115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown