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

Model Number	M00539310
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific that a flexima biliary stent was attempted to be placed in the distal bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(4)2023.During the procedure, after the guidewire was correctly positioned, an attempt was made to cross the stenosis, but despite several maneuvers, the physician was unable to cross the stenosis.After several attempts, the procedure was cancelled.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific that a flexima biliary stent was attempted to be placed in the distal bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, after the guidewire was correctly positioned, an attempt was made to cross the stenosis, but despite several maneuvers, the physician was unable to cross the stenosis.After several attempts, the procedure was cancelled.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned flexima biliary stent and delivery system were analyzed, and a visual evaluation noted that the delivery system and stent were free of obvious kinks and bends.Additionally, the outer diameter of the push catheter and the outer diameter of the stent were measured and both components were found within manufacturing specifications.No other problems with the device were noted.Therefore, the reported event of stent difficult to advance was not confirmed.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Considering all available information, the returned device met all manufacturing requirements, and no abnormalities were reported during the manufacturing process.The device did not show evidence of either the alleged problem or any defect that could have contributed to the event reported.Therefore, the most probable cause is no problem detected.

• 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: 17100632
• Report Number: 3005099803-2023-02914
• Device Sequence Number: 16618098
• Product Code: FGE
• UDI-Device Identifier: 08714729162629
• UDI-Public: 08714729162629
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

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: 12/14/2025
• Device Model Number: M00539310
• Device Catalogue Number: 3931
• Device Lot Number: 0030719722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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: Female