MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION? HI-FLO? FATHOM?-16 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	M001195740
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a vessel spasm requiring intervention.Patient was under local anesthesia.The target lesion was located in the mildly tortuous hepatic artery.A direxion hi-flo fathom, 16 system was selected for use.During the procedure, upon delivering the dose, it was noted that the nitinol hypotube broke in half revealing the yellow sheath.Upon removing the microcatheter, vessel spasm occurred.An intervention was performed with no luck to open back up the vessel.The procedure was cancelled.
Additional Manufacturer Narrative
G4: premarket / 510(k): k142259, k163701.
Additional Manufacturer Narrative
G4 - premarket / 510(k): k142259, k163701.The device was not returned for evaluation.However, an analysis was concluded based on the received photo of the complaint device.Analysis revealed a nickel shaft fracture near the strain relief with the inner lumen exposed.
Event or Problem Description
It was reported that the patient experienced a vessel spasm requiring intervention.Patient was under local anesthesia.The target lesion was located in the mildly tortuous hepatic artery.A direxion hi-flo fathom - 16 system was selected for use.During the procedure, upon delivering the dose, it was noted that the nitinol hypotube broke in half revealing the yellow sheath.Upon removing the microcatheter, vessel spasm occurred.An intervention was performed with no luck to open back up the vessel.The procedure was cancelled.It was further reported the issue was reported via attached voluntary medwatch report.

• Brand Name: DIREXION? HI-FLO? FATHOM?-16 SYSTEM
• 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: 21893692
• Report Number: 2124215-2025-23957
• Device Sequence Number: 8162321
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: (01)08714729839712(17)261114(10)35281633
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142259
• 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): 05/08/2025

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 Model Number: M001195740
• Device Catalogue Number: M001195740
• Device Lot Number: 0035281633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/08/2025
• Date Device Manufactured: 11/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic