MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. PRONTO V4; EXTRACTION CATHETER

Model Number	4006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The distal tip of the pronto v4 catheter became disconnected from the rest of the catheter while being used in the peripheral vascular system, actual location not specified.The tip was able to be retrieved from the body and no patient harm ensued.The pronto was used to aspirate clot in the distal left leg during an emergent case.When the operator went to remove the wire, the distal 7-10 cm of the catheter was sheared off.However, the fact that it was sheared off was not noticed at that time and the tip was left in the patient.The next day, the physician went in as planned to fix the leg.During the procedure, the physician had a balloon down and noticed that there was an extra radiopaque marker.The physician was able to snare a 8 cm segment of the pronto.

• Brand Name: PRONTO V4
• Common Device Name: EXTRACTION CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 5704244
• Report Number: 2134812-2016-00040
• Device Sequence Number: 29778
• Product Code: DXE
• UDI-Device Identifier: M20640060
• UDI-Public: M20640060
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2016

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: Physician
• Device Model Number: 4006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2016
• Supplement Report FDA Received Date: 07/13/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention