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

Catalog Number	REF 7001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a left ica terminus occlusion.A first pass with freeclimb 70 reperfusion system and synchro select standard left some residual clot in the mid portion of the m1 segment.During the second pass the devices were advanced into mid m1 segment.Tenzing 7 and synchro wire were removed and aspiration was performed through freeclimb 70 for roughly 1-2 minutes.Freeclimb 70 catheter was retracted into the zoom 88 catheter at the horizontal petrous segment of the left ica.A contrast injection through the zoom 88 catheter identified extravasation at left m1 segment.A dissection occurred.

• 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: 18944700
• Report Number: 3016522967-2024-00004
• Device Sequence Number: 19541383
• Product Code: NRY
• UDI-Device Identifier: 00853799007497
• UDI-Public: (01)00853799007497(17)260108(10)24012403
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K223530N/A
• 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): 03/18/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2026
• Device Catalogue Number: REF 7001
• Device Lot Number: 24012403
• 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: 02/22/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: FULL LENGTH 070 REPERFUSION SYSTEM
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown