MAUDE Adverse Event Report: ASAHI INTECC CROSSLEAD PENETRATION; GUIDEWIRE

Catalog Number	CLP01430S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While torquing wire in calcified a.T.Distal tip of wire came off.Left in patient, no injury but have device to return.Returning wire - was in body and not resterilized.

• Brand Name: CROSSLEAD PENETRATION
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 22833370
• Report Number: 3004718255-2025-00390
• Device Sequence Number: 15833358
• Product Code: DQX
• UDI-Device Identifier: 04547327143875
• UDI-Public: (01)04547327143875(17)271130(10)241207A371
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/18/2025
• Report Date (Section F): 08/18/2025

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: CLP01430S
• Device Lot Number: 241207A371
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/07/2025
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 120 KG
• Date Report Sent to FDA: 08/18/2025