MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUSELECT; CATHETER, CONTINUOUS FLUSH

Model Number	2213-02
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the radiopaque marker was missing.A 130cm truselect microcatheter was selected for use in a y90 mapping procedure.During insertion it was observed that the microcatheter did not have a radiopaque marker.A new microcatheter was opened, which did have the radiopaque marker.The procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the 130cm truselect microcatheter was returned to boston scientific for analysis.The device was visually and microscopically inspected for any damage or irregularities.The device showed that it was in the body due to the blood on the device.The device showed that it was separated at the distal end located 126.9cm from the hub.The separation at this location did reveal that the marker band was missing.Device analysis determined the condition of the returned device was consistent with the reported information.The device was separated, and the marker band was missing.
Event or Problem Description
It was reported that the radiopaque marker was missing.A 130cm truselect microcatheter was selected for use in a y90 mapping procedure.During insertion it was observed that the microcatheter did not have a radiopaque marker.A new microcatheter was opened, which did have the radiopaque marker.The procedure was completed.No patient complications were reported.

• Brand Name: TRUSELECT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18302622
• Report Number: 2124215-2023-69171
• Device Sequence Number: 16950259
• Product Code: KRA
• UDI-Device Identifier: 08714729976653
• UDI-Public: 08714729976653
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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: 09/05/2025
• Device Model Number: 2213-02
• Device Catalogue Number: 2213-02
• Device Lot Number: 0032369156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Unknown