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

Model Number	M00539200
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter's phone number is (b)(6); reported here as it exceeded the number of character limit.Block h6: imdrf device code a0401 captures the reportable investigation findings of catheter guide detached.Block h11: a flexima biliary preloaded stent was received for analysis.The stent was undeployed and the guide catheter cap was detached.Visual examination found the push catheter suture hole torn, and the push catheter kinked.No other damages were noted on the device.Product analysis confirmed the reported event of stent failure to deploy.The investigation concluded the reported event, and additional observed damages were caused due to the excessive force applied to the device during the stent deployment attempt while the guidewire was not completely retracted into the delivery system.Therefore, a review and analysis of all available information indicate that the most probable cause is failure to follow instructions.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use/product label.It was reported that the guidewire was inside the patient during the attempted deployment.Per the ifu, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." the physician did not follow the deployment steps.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be implanted to treat a bile duct stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the front end of the stent could not be deployed.The procedure was completed with another flexima biliary preloaded 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.Note: it was reported that the guidewire was inside the patient during the attempted deployment.Per the ifu, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." the physician did not follow the deployment steps.This complaint has been deemed mdr reportable based on the investigation results, which revealed that the guide catheter was detached.Please refer to block h11 for full investigation details.

• 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: 20588829
• Report Number: 3005099803-2024-05497
• Device Sequence Number: 6558363
• Product Code: FGE
• UDI-Device Identifier: 08714729337362
• UDI-Public: 08714729337362
• 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
• Report Date (Section B): 11/01/2024

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: M00539200
• Device Catalogue Number: 3920
• Device Lot Number: 0031997477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 11/01/2024
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 62 KG