MAUDE Adverse Event Report: ASAHI INTECC CO LTD CROSSLOO[; PERIPHERAL VASCULAR GUIDE WIRE

Model Number	LPM01830P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an asahi crossloop guide wire was used for a plain old balloon angioplasty (poba) to treat a heavily calcified chronic total occlusion (cto) in the anterior tibial artery (ata).The crossloop guide wire was torqued three times clockwise and then three times counterclockwise to cross the lesion.The crossloop guide wire went out of the vessel during manipulation and the tip of guide wire was fractured.As a remedial action, a surgical incision was performed to remove the guide wire fragment, and the guide wire fragment was successfully removed.Due to the heavy calcification of the vessel, it was determined that no additional treatment for the perforation was necessary.In addition, the attempt to cross the lesion was abandoned and the procedure was discontinued.It was informed that there were no adverse patient effects associated with this event and the patient was discharged.Mfr report #: 3003775027-2026-00141.

• Brand Name: CROSSLOO[
• Common Device Name: PERIPHERAL VASCULAR GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO LTD; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 25892001
• Report Number: 3004718255-2026-00030
• Device Sequence Number: 13216049
• Product Code: DQX
• UDI-Device Identifier: 04547327155403
• UDI-Public: (01)04547327155403(17)281231(10)260114A06A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2026
• Report Date (Section F): 07/21/2026

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
• Device Model Number: LPM01830P
• Device Lot Number: 260114A06A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2026
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/21/2026