MAUDE Adverse Event Report: ROUTE 92 MEDICAL, INC. FULL LENGTH 070 REPERFUSION SYSTEM (FREECLIMB 70 REPERFUSION SYSTEM); PERCUTANEOUS CATHETER

Catalog Number	REF 7001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tenzing 7 separated at the proximal marker inside a patient.The physician was able to retrieve the tip of the tenzing 7 with a snare and the patient was fine.

• Brand Name: FULL LENGTH 070 REPERFUSION SYSTEM (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; 155 bovet road suite 100; san mateo CA 94402
• Manufacturer Contact: matthew fortson ; 155 bovet road suite 100; san mateo, CA 94402
• MDR Report Key: 17822673
• Report Number: 3016522967-2023-00002
• Device Sequence Number: 6205559
• Product Code: NRY
• UDI-Device Identifier: 00853799007541
• UDI-Public: (01)00853799007541(17)250510(19)23051001
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/28/2023

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: 05/10/2025
• Device Catalogue Number: REF 7001
• Device Lot Number: 23051001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 REPERFUSION SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female