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

Catalog Number REF 7001

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/28/2023

Event Type  malfunction  

Event 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)
• 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; 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
• MDR Text Key: 324329004
• Report Number: 3016522967-2023-00002
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00853799007541
• UDI-Public: (01)00853799007541(17)250510(19)23051001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223530
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REF 7001
• Device Lot Number: 23051001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: FREECLIMB 70 REPERFUSION SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female