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

Model Number	M00539210
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was used in the common bile duct to treat a choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guide catheter broke when the stent was attempted to be released.The procedure was completed with an alternative device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on july 17, 2024.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was used in the common bile duct to treat a choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guide catheter broke when the stent was attempted to be released.The procedure was completed with an alternative device.There were no patient complications reported as a result of this event.Additional information received on july 17, 2024: the broken inner guide catheter remained within the push catheter, and the delivery system was removed intact.The procedure was completed with another flexima biliary stent.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was used in the common bile duct to treat a choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guide catheter broke when the stent was attempted to be released.The procedure was completed with an alternative device.There were no patient complications reported as a result of this event.Additional information received on july 17, 2024: the broken inner guide catheter remained within the push catheter, and the delivery system was removed intact.The procedure was completed with another flexima biliary stent.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: a flexima biliary preloaded stent was received for analysis.The stent was already deployed.Visual inspection found the guide catheter kinked, stretched, and detached.The push catheter suture hole was torn.No other problems were noted with the device.The reported events of catheter-guide break and stent failure to deploy were confirmed and could have occurred as a result of the difficulties during the procedure when trying to deploy the stent.If the device had pressure when trying to deploy the stent possibly due to the physician's technique or tortuosity of the procedure, it is most likely that the device was unable to deploy the stent and damaged the guide catheter.It is most likely that the guide catheter was kinked, stretched, and then detached due to the force being applied when the stent was attempted to be deployed.Since the device was unable to deploy, it is possible that the push catheter suture hole was torn by the pressure that the suture was adding to the suture hole.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with 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: 19715643
• Report Number: 3005099803-2024-03277
• Device Sequence Number: 12956355
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2024

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: 08/23/2025
• Device Model Number: M00539210
• Device Catalogue Number: 3921
• Device Lot Number: 0030013142
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 07/17/2024; 09/19/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/13/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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