MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC PRONTO V3; CATHETER

Model Number	5003
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has returned for evaluation and an investigation has been opened to review device and history records, and risk documentation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: procedure went as planned, but when removing the pronto v4 it started unraveling, and ended up separating.Entire catheter stayed on wire so we're able to remove everything, and nothing the broke off in patient.No harm to patient, or medical intervention required.
Additional Manufacturer Narrative
A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.The polyimide guidewire lumen was completely separated from the body of the catheter.There was no other damage found to the catheter.The guidewire lumen was pulled away from the catheter shaft.This action happens outside of the body while the catheter is being removed simultaneously with the guidewire and the guidewire and catheter are pulled in opposite directions causing the tearing of the lumen.

• Brand Name: PRONTO V3
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10687640
• Report Number: 2134812-2020-00076
• Device Sequence Number: 2954940
• Product Code: DXE
• UDI-Device Identifier: 10841156100308
• UDI-Public: (01)10841156100308
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: 01/23/2022
• Device Model Number: 5003
• Device Catalogue Number: 5003
• Device Lot Number: 666171
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1