MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CROSSWALK; CATHETER, PERCUTANEOUS

Model Number	PSC18150A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Lower extremity angiogram on patient with known disease (highly calcified) osteomyelitis of right great toe-attempt for revascularization.Crosswalk support catheter tip broke off in the calcium of right tibial artery.During peripheral intervention distal end of plastic catheter became dislodged from catheter sheath.Tip of device imbedded in calcium in vessel, unable to snare or remove.Physician deemed it safe, due to location to leave imbedded in vessel.

• Brand Name: CROSSWALK
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3002 dow ave., suite 212; tustin CA 92780
• MDR Report Key: 22737028
• Report Number: 22737028
• Device Sequence Number: 21158685
• Product Code: DQY
• UDI-Device Identifier: 04547327133524
• UDI-Public: (01)04547327133524
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/15/2025
• Report Date (Section F): 07/15/2025

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 Model Number: PSC18150A
• Device Catalogue Number: PSC18150A
• Device Lot Number: 240729K05A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Date Report Sent to FDA: 07/15/2025