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

Model Number	M00539270
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during a cholecystectomy procedure performed on (b)(6) 2022.During the procedure, it was noted that the stent failed to release.The procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.Investigation results revealed that the guide catheter was detached, therefore this event has been deemed an mdr reportable event.
Additional Manufacturer Narrative
(b)(4).The returned flexima biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached and stretched.The suture thread was not returned for analysis and the stent was returned in good condition.No other problems with the device were noted.A functional evaluation could not be performed due to the condition of the device.The reported event of stent failure to deploy was confirmed.Taking all available information into consideration, most likely, during the procedure the device was subjected to stress caused either by the customer technique and/or a tortuous anatomy or tight stenosis.Once the device experienced these difficulties, the user may have experienced difficulties in removing the guide catheter, this may have led the user to apply extra force causing the guide catheter to stretch and detach.These conditions may have caused difficulties in deploying the stent.Therefore, the most probable root cause is adverse event related to the procedure.

• 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: 16194170
• Report Number: 3005099803-2022-07930
• Device Sequence Number: 4385907
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: 08714729162582
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 01/18/2023

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: 01/23/2025
• Device Model Number: M00539270
• Device Catalogue Number: 3927
• Device Lot Number: 0028732798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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: Unknown