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

Model Number	M00539270
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to treat bile duct stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During unpacking, it was noted that the coating of the guide catheter peeled off.The procedure was completed using another flexima biliary stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to treat bile duct stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During unpacking, it was noted that the coating of the guide catheter peeled off.The procedure was completed using another flexima biliary stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on february 21, 2024: it was reported that the guide catheter was not peeled off.During the attempted deployment, the handle got stuck and could not be operated normally, which resulted in the stent not being deployed.Boston scientific no longer considers this to be a reportable event.
Additional Manufacturer Narrative
Block b5, block h6 (device codes) and block h10 have been updated with the additional information received on february 21, 2024.Block h10: a flexima biliary stent and delivery system were returned for analysis.Visual examination of the returned device found the stent still attached to the push catheter.The stent, guide catheter and push catheter suture hole were inspected, and no damages were noted.The touhy borst was detached from the guide catheter hub; however, the male luer has evidence of adhesive indicating that the device was bonded correctly during the manufacturing process.Functional inspection was performed, the stent was deployed without problems and no resistance was felt.The reported events of stent failure to deploy and touhy borst failure to loosen could not be confirmed.The observed problem of touhy borst detached from the guide catheter hub was likely due to factors encountered during the procedure such as the handling of the device, technique used by the physician (force applied), and the possibility that the incorrect luer was loosened.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, this 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: 18487981
• Report Number: 3005099803-2024-00010
• Device Sequence Number: 17890322
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: 08714729162582
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/08/2024

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: 07/27/2026
• Device Model Number: M00539270
• Device Catalogue Number: 3927
• Device Lot Number: 0032106793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 70 KG