MAUDE Adverse Event Report: ASAHI INTECC, INC. CROSSLEAD; GUIDEWIRE

Catalog Number	CLN03530A
Medical Device Problem Codes	Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
R cfa with 4fr micro puncture kit.Introducer exchanged for 6fr x 11cm pinnacle sheath over the crosslead pro.035 x 300cm.,.035 x 90 cm and a 5fr sos reverse curve catheter was used to access over the bifurcation.Crosslead wire was advanced down the left common iliac, through the left external iliac into the left superficial femoral artery.5fr sos catheter was removed and 6fr x 65cm cook sheath was inserted then a.035 x 90cm straight tip trailblazer was advanced over the bifurcation into the left common femoral artery.Upon trying to remove the crosslead, there was a lot of resistance pulling the wire back.Once the wire was out of the catheter, they noticed the integrity of the wire was compromised.No issues prior to the trailblazer being used.It was a successful procedure.

• Brand Name: CROSSLEAD
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC, INC.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 23783485
• Report Number: 3004718255-2025-00406
• Device Sequence Number: 12019474
• Product Code: DQX
• UDI-Device Identifier: 04547327140195
• UDI-Public: (01)04547327140195(17)280430(10)250520A81
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/11/2025
• Report Date (Section F): 12/11/2025

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: CLN03530A
• Device Lot Number: 250520A081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/26/2025
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 12/11/2025