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

Model Number	M00540640
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: the initial reporter's city is (b)(6).Block h6: imdrf device code a0501 captures the reportable event of a detached pigtail.Imdrf impact code f2301 captures the reportable event of retrieval of the detached pigtail with a snare.
Event or Problem Description
It was reported to boston scientific corporation that a flexima nasobiliary catheter was to be used during a procedure performed on (b)(6) 2023.During the procedure, the tip of the flexima nasobiliary catheter was stiff upon advancing through the guidewire.The insertion was continued, and the tip of the pigtail became separated and it fell into the patient.The separated tip was removed from the body using a snare, and the procedure was completed with another flexima nasobiliary catheter.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIMA NASOBILIARY CATHETER KIT
• 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: 18368706
• Report Number: 3005099803-2023-06750
• Device Sequence Number: 7617747
• Product Code: FGE
• UDI-Device Identifier: 08714729337454
• UDI-Public: 08714729337454
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982508
• 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): 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2024
• Device Model Number: M00540640
• Device Catalogue Number: 4064
• Device Lot Number: 0027728813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown