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

Model Number	M00539230
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2024-03894 and 3005099803-2024-03895 for the associated device information.It was reported to boston scientific corporation that a flexima biliary preloaded stent was used in the bile duct for stricture management during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was unable to deploy as the suture was unable to be released.A second flexima biliary preloaded stent of a different size was used but the same problem occurred.The procedure was cancelled due to device availability.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2024-03894 and 3005099803-2024-03895 for the associated device information.It was reported to boston scientific corporation that a flexima biliary preloaded stent was used in the bile duct for stricture management during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was unable to deploy as the suture was unable to be released.A second flexima biliary preloaded stent of a different size was used but the same problem occurred.The procedure was cancelled due to device availability.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h11: a flexima biliary preloaded stent was received for analysis.Media inspection on the photo of the device provided found that the guide catheter was kinked.Visual inspection found that the guide catheter was kinked, and the cap was detached.The push catheter suture hole was torn, and the stent was not deployed.No other problems were noted with the device.Product analysis confirmed the reported events of suture deployment issue and stent failure to deploy, and these events could have occurred as a result of the difficulties when trying to deploy the stent.If the device had pressure during the attempted deployment possibly due to the physician's technique, it is most likely that the stent could not be deployed, and the push catheter suture hole was torn by the pressure added by the suture.Furthermore, it is also possible that the pressure being applied when deploying the stent resulted in the observed event of the guide catheter being kinked and since the guide catheter was most likely stuck, it could not be released from the delivery system, and this would result in the guide catheter being detached from the cap.The observed event of guide catheter kinked would have then affected the way the suture is supposed to be deployed from the stent and push catheter.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

• 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: 19969023
• Report Number: 3005099803-2024-03895
• Device Sequence Number: 8923633
• Product Code: FGE
• UDI-Device Identifier: 08714729162544
• UDI-Public: 08714729162544
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 07/11/2026
• Device Model Number: M00539230
• Device Catalogue Number: 3923
• Device Lot Number: 0031996160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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