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

Model Number	M00539250
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was used in the bile duct to treat a choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the guide catheter broke when the stent was released.The procedure was completed with a non-boston scientific device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: a flexima biliary preloaded device was received for analysis; the stent and the suture were not returned.Visual inspection found a guidewire stuck within the guide catheter.The guide catheter was detached, buckled, and kinked.The push catheter suture hole was torn.No other problems were noted with the device.Product analysis confirmed the reported events of catheter-guide break and stent failure to deploy.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.The ifu states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." however, it was observed that the device was received with a guidewire completely stuck, which means that the stent was tried to be deployed but due to the guidewire being still inside at the time of deployment, it became stuck.Furthermore, the guide catheter was most likely buckled, kinked, and was then detached due to the force applied when it was felt that the stent was not being deployed.These events could have also occurred due to the fact that the ifu was not followed, or also due to the complications that could have appeared during the procedure causing the guide catheter being unable to handle the amount of pressure that was used on it.If the device was not deploying the stent due to the guidewire not being retracted, there is a possibility that the same force applied when trying to deploy the stent made the push catheter suture hole torn and the suture detached.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was used in the bile duct to treat a choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the guide catheter broke when the stent was released.The procedure was completed with a non-boston scientific device.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIMA 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: 19536628
• Report Number: 3005099803-2024-02798
• Device Sequence Number: 8252089
• Product Code: FGE
• UDI-Device Identifier: 08714729162568
• UDI-Public: 08714729162568
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: 07/18/2026
• Device Model Number: M00539250
• Device Catalogue Number: 3925
• Device Lot Number: 0032046938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown