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

Catalog Number	7001
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was suffering from a stroke with the right internal carotid artery blocked.Physician advanced free climb 70 up into the rica and brought it to m1 segment without any issue.After connecting the aspiration the physician felt resistance pulling back the catheter.The physician completely removed the system from the patient and found the catheter had unraveled.

• Brand Name: FREECLIMB 70 REPERFUSION SYSTEM
• 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 road suite 100; san mateo CA 94402
• Manufacturer Contact: matthew fortson ; 155 bovet road suite 100; san mateo, CA 94402 ; 6503800495
• MDR Report Key: 20656752
• Report Number: 3016522967-2024-00006
• Device Sequence Number: 4499389
• Product Code: NRY
• UDI-Device Identifier: 00853799007541
• UDI-Public: (01)00853799007541(17)260521(10)24051309
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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 Expiration Date: 05/21/2026
• Device Catalogue Number: 7001
• Device Lot Number: 24051309
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: FREECLIMB 70 SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown