MAUDE Adverse Event Report: ROUTE 92 MEDICAL, INC. FREECLIMB 70 REPERFUSION CATHETER WITH TENZING 7; PERCUTANEOUS CATHETER

Catalog Number	7001-70-132R
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 7f guide sheath severely kinked during use making withdrawal of a freeclimb 70 catheter through the guide sheath difficult.The kinked sheath damaged the tip of the freeclimb 70 catheter during withdrawal.A subsequent contrast injection through the guide sheath embolized the distal marker band from the freeclimb 70 into the a2 artery.One attempt to retrieve the marker band with the freeclimb 54 and a stent retriever was unsuccessful.The marker band was not flow limiting so it was left in place.During withdrawal into the kinked guide sheath, the distal end of the freeclimb 54 was damaged and stretched.Physician acknowledged that considerable force was required to retract the catheter(s) through the kinked sheath.
Additional Manufacturer Narrative
Review of the returned products substantiated the report.

• Brand Name: FREECLIMB 70 REPERFUSION CATHETER WITH TENZING 7
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ROUTE 92 MEDICAL, INC.; 155 bovet road suite 100; san mateo CA 94402
• Manufacturer (Section G): ROUTE 92 MEDICAL, INC.; 155 bovet suite 100; san mateo CA 94402
• Manufacturer Contact: matthew fortson ; 155 bovet road suite 100; san mateo, CA 94402
• MDR Report Key: 24437726
• Report Number: 3016522967-2026-00001
• Device Sequence Number: 10212780
• Product Code: NRY
• UDI-Device Identifier: 00853799007541
• UDI-Public: (01)00853799007541(17)271106(10)25110606
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K223530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7001-70-132R
• Device Lot Number: 25110606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7F GUIDE SHEATH.; FREECLIMB 54.; FREECLIMB 70.; TREVO.
• Patient Sex: Unknown