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

Model Number	M00539260
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the biliary tract performed on (b)(6) 2022.During the procedure, it was noted that the stent did not deploy successfully.The procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that the guide catheter was detached, therefore this event has been deemed an mdr reportable event.
Additional Manufacturer Narrative
Medical device code a0401 captures the reportable investigation results of guide catheter detached.The returned flexima plus biliary stent was analyzed, and a visual evaluation noted that the guide catheter detached, and the guide catheter hub was not returned for analysis.A bent was found on proximal section of push catheter.No other problems with the device were noted.The reported event was confirmed.Taking all available information into consideration, most likely, user manipulation during preparation and/or technique to the delivery system caused the push catheter to kink.The user may have also experienced difficulties while retracting the guide catheter and deploying the stent, causing the user to apply additional force/tension.As a consequence of the additional force/tension the guide catheter detached.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: 16479156
• Report Number: 3005099803-2023-00583
• Device Sequence Number: 11562984
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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: 03/09/2025
• Device Model Number: M00539260
• Device Catalogue Number: 3926
• Device Lot Number: 0029021823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 70 KG