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

Catalog Number	7001-70-132R
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation therefore root cause of the problem cannot be determined.Manufacturing records for this lot were reviewed and did not reveal any discrepancies, design, or quality concerns.
Event or Problem Description
Patient with a mid-right m1 occlusion.Penumbra bmx 96 sheath and freeclimb 70 system were used and aspiration was initiated.Catheters were withdrawn with some resistance, and it was found the freeclimb 70 tip had separated.Imaging showed the tip embolized to the anterior segment (a1/a2), but did not cause an infarct and blood flow continued, therefore removal was not attempted.Second pass with a new freeclimb 70 system performed without incident but unsuccessful.Third pass with a stent retriever performed and the clot in the m1 was removed.Physician noted the clinical condition of the patient continued to deteriorate from the original infarct, and the embolized tip appeared to have no clinical impact on the patient.

• 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 suite 100; san mateo CA 94402
• Manufacturer Contact: matthew fortson ; 155 bovet road suite 100; san mateo, CA 94402
• MDR Report Key: 20656277
• Report Number: 3016522967-2024-00007
• Device Sequence Number: 4499372
• Product Code: NRY
• UDI-Device Identifier: 00853799007541
• UDI-Public: (01)00853799007541(17)260822(10)24082103
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2026
• Device Catalogue Number: 7001-70-132R
• Device Lot Number: 24082103
• 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: 10/07/2024
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2024
• 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: BMX 96 SHEATH.; FREECLIMB 70 SYSTEM.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Female