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

Model Number	M001394111750
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal marker was missing.A 175cm truselect was selected for use in a prostatic artery embolization procedure.During removal from the loop, there was no distal marker.The procedure was completed with another the same device.There were no patient complications and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Microscopic inspection found multiple kinks at the distal tip of device and a shaft separation 175.5cm from the hub.The separated section was not received.Visual inspection revealed the shaft length was 175.5cm from hub to shaft separation location.
Event or Problem Description
It was reported that the distal marker was missing.A 175cm truselect was selected for use in a prostatic artery embolization procedure.During removal from the loop, there was no distal marker.The procedure was completed with another the same device.There were no patient complications and the patient was stable post procedure.

• 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: 20925658
• Report Number: 2124215-2024-78953
• Device Sequence Number: 5294162
• Product Code: KRA
• UDI-Device Identifier: 08714729976677
• UDI-Public: 08714729976677
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: 05/01/2026
• Device Model Number: M001394111750
• Device Catalogue Number: M001394111750
• Device Lot Number: 0033940260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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: 65 YR
• Patient Sex: Female