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

Catalog Number REF 7001

Device Problem Insufficient Information (3190)

Patient Problem Vascular Dissection (3160)

Event Date 02/21/2024

Event Type  Injury  

Event 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wire were removed and aspiration was performed through freeclimb 70 for roughly 1-2 minutes.Freeclimb 70 catheter was retracted into the zoom 88 catheter at the horizontal petrous segment of the left ica.A contrast injection through the zoom 88 catheter identified extravasation at left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
• Type of Device: 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
• MDR Text Key: 338161227
• Report Number: 3016522967-2024-00004
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00853799007497
• UDI-Public: (01)00853799007497(17)260108(10)24012403
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223530N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: REF 7001
• Device Lot Number: 24012403
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FULL LENGTH 070 REPERFUSION SYSTEM
• Patient Outcome(s): Life Threatening