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

Model Number	M00539230
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of push catheter broken into more than two pieces.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the bile duct to treat gallstones during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.The patient's anatomy was normal in shape and was dilated by 1 cm prior to stent placement.During the procedure, the push catheter was broken into more than two pieces, and the stent did not deploy.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: it was reported that the guidewire was in the delivery system during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed.".
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the bile duct to treat gallstones during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.The patient's anatomy was normal in shape and was dilated by 1 cm prior to stent placement.During the procedure, the push catheter was broken into more than two pieces, and the stent did not deploy.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: it was reported that the guidewire was in the delivery system during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed.".
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of push catheter broken into more than two pieces.Block h11: a flexima biliary stent was received for analysis.Visual examination of the returned device found the guide catheter kinked in different sections, stretched, and detached.The push catheter suture hole was torn with the stent still attached to it, and the suture was detached.No other problems were noted with the stent and delivery system.Product analysis did not confirm the reported event of push catheter break as the push catheter was returned without breaks.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the guidewire was in the delivery system during the attempted deployment.However, 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".Since the ifu were not followed, this likely caused the stent failure to deploy.The investigation concluded that all the additional observed damages were likely due to user manipulation.The user likely experienced difficulties to pull out the guide catheter and used excessive force contributing to the observed damages.Therefore, a review and analysis of all available information indicated that the most probable cause is failure to follow instructions.

• 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: 20902437
• Report Number: 3005099803-2024-06219
• Device Sequence Number: 5052911
• Product Code: FGE
• UDI-Device Identifier: 08714729162544
• UDI-Public: 08714729162544
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: 07/25/2026
• Device Model Number: M00539230
• Device Catalogue Number: M00539230
• Device Lot Number: 0032092293
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 56 KG