MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC PRONTO V4; CATHETER

Model Number	4005
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation; however, an image from the site was received.The reported "plastic" appeared to visually align with the ptfe inner core, which is a process aid used during manufacturing and removed.Controls and inspections are in place to mitigate this occurrence and an internal nonconformance was initiated to further investigate.If further information is received a follow-up report will be submitted.
Event or Problem Description
Customer removed the catheter after aspirating.On the back table, as the customer was flushing the aspirate through the filter basket, a long string of what appears to be plastic came out longitudinally.No patient impact or injury was reported.

• Brand Name: PRONTO V4
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8619806
• Report Number: 2134812-2019-00035
• Device Sequence Number: 16208996
• Product Code: DXE
• UDI-Device Identifier: 30841156100227
• UDI-Public: (01)30841156100227
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

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: 02/06/2021
• Device Model Number: 4005
• Device Lot Number: 641913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR