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

Model Number	M00539260
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation finding of stent barb torn.Block h11: a flexima biliary stent was returned for analysis; the delivery system was not returned.Visual examination of the returned device found one of the stent barb torn.No other problems were noted to the stent.Taking all available information into consideration, the investigation concluded that the reported event and observed damages were likely due to the physician not following the ifu during the procedure.It may be that not "retracting" the guidewire into the scope could have put more pressure to the handle, which caused the stent not to deploy correctly and one of the stent barb to be torn, which limited the performance of the device and contributed to the reported event and observed damages.Therefore, 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 ifu (instructions for use) / product label.The complainant reported that the guidewire was inside the patient during the attempted deployment.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.".
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the biliary tract during an implantation procedure performed on (b)(6) 2024.During the procedure, the stent could not be deployed.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.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent barb was torn.Please see block h10 for full investigation details.It was reported that the guidewire was inside the patient 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 cannot be fully deployed.".

• 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: 19537391
• Report Number: 3005099803-2024-02836
• Device Sequence Number: 6425432
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: 08714729162575
• 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): 06/14/2024

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: 10/04/2026
• Device Model Number: M00539260
• Device Catalogue Number: 3926
• Device Lot Number: 0032578026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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 Sex: Unknown