MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	31775
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date of (b)(6) 2020 is an estimated based of the aware date of (b)(6) 2021 as the exact date was not reported.Initial reporter city: (b)(6).
Event or Problem Description
It was reported the guidewire was difficult to remove.A 7.3 flexima apdl was selected for use in a liver abscess drainage procedure.During the procedure, the device was inserted into the abscess over a guidewire.An attempt was made to remove the metal stylet, but was unsuccessful.Subsequently, another attempt was made to remove the device, leaving the guide wire, but was unsuccessful, so everything was removed from the patient.The procedure was completed with another device with no complications reported.
Additional Manufacturer Narrative
B3.The event date of 01jul2020 is an estimated based of the aware date of 30jul2021 as the exact date was not reported.E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the catheter was returned with a guidewire loaded and stuck.Moreover, the catheter was detached at the distal end section.The distal end section showed guidewire residue inside of it.Additionally, the metal cannula was not returned.Microscope analysis confirmed the catheter was detached at the distal end section and guidewire residue was inside this section.The catheter distal section was deformed due to guidewire residue inside.
Event or Problem Description
It was reported the guidewire was difficult to remove.A 7.3 flexima apdl was selected for use in a liver abscess drainage procedure.During the procedure, the device was inserted into the abscess over a guidewire.An attempt was made to remove the metal stylet, but was unsuccessful.Subsequently, another attempt was made to remove the device, leaving the guide wire, but was unsuccessful, so everything was removed from the patient.The procedure was completed with another device with no complications reported.

• Brand Name: FLEXIMA APDL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12360806
• Report Number: 2134265-2021-10642
• Device Sequence Number: 3794930
• Product Code: FFA
• UDI-Device Identifier: 08714729300670
• UDI-Public: 08714729300670
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 03/24/2023
• Device Model Number: 31775
• Device Catalogue Number: 31775
• Device Lot Number: 0025401000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE-RADIFOCUS 0.035INCH; GUIDEWIRE-RADIFOCUS 0.035INCH; GUIDEWIRE-RADIFOCUS 0.035INCH