MAUDE Adverse Event Report: ASAHI INTECC CROSSWALK; CATHETER

Catalog Number	PSC35170A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The crosswalk broke into 2 pieces by over torquing the catheter while trying to cross the right sfa.The physician said he over torqued the catheter.The device was able to be removed by pulling the sheath out while the crosswalk was still in the sheath.The physician then pulled everything back in the sheath and all components were removed including both pieces of the crosswalk.There was no harm to the patient.Everything was removed from the body and pressure was held on the radial artery for access closure.Patient did fine.Patient did fine.Patient was discharged in normal fashion.

• Brand Name: CROSSWALK
• Common Device Name: CATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 23096854
• Report Number: 3004718255-2025-00393
• Device Sequence Number: 18487601
• Product Code: DQY
• UDI-Device Identifier: 04547327133630
• UDI-Public: (01)04547327133630(17)270930(10)240926K20A
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2025
• Report Date (Section F): 09/19/2025

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 Catalogue Number: PSC35170A
• Device Lot Number: 240926K20A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/28/2025
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 86 KG
• Date Report Sent to FDA: 09/19/2025