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

Model Number	32337
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter split.A vtcb/8.3 flexima regular w/ro flexima was selected for use in a biliary drainage procedure.After placing the device into the patient, it was noted that the catheter has split when attempting to remove the inner dilator.The device was removed over the wire.Another catheter was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Date of event: no date provided, used the first date in the month of the aware date.Initial reporter title, and initial reporter last name were reported as: (b)(6).
Event or Problem Description
It was reported that the catheter split.A vtcb/8.3 flexima regular w/ro flexima was selected for use in a biliary drainage procedure.After placing the device into the patient, it was noted that the catheter has split when attempting to remove the inner dilator.The device was removed over the wire.Another catheter was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
E1: initial reporter title and initial reporter last name: additional information.B3: date of event: no date provided, used the first date in the month of the aware date.

• Brand Name: FLEXIMA
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15506176
• Report Number: 2124215-2022-38016
• Device Sequence Number: 5212692
• Product Code: FGE
• UDI-Device Identifier: 08714729454953
• UDI-Public: 08714729454953
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K023870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 01/10/2025
• Device Model Number: 32337
• Device Catalogue Number: 32337
• Device Lot Number: 0028659477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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