MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC PRONTO V4 5.5F; CATHETER

Model Number	4005
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after investigation.
Event or Problem Description
It was reported that the pronto catheter would not advance into the vessel.Additional information: during an angiogram through the left femoral.The physician was unable to advance the pronto into the patients vessel the physician confirmed that there was no harm or injury to the patient from the device.There was no reported defects or kinks to the catheter.The patient was transferred to hospital to perform a bypass to the peroneal artery but failed.They are reported to still be in hospital.
Event or Problem Description
It was reported that the pronto catheter would not advance into the vessel.Additional information: during an angiogram through the left femoral.The physician was unable to advance the pronto into the patients vessel the physician confirmed that there was no harm or injury to the patient from the device.There was no reported defects or kinks to the catheter.The patient was transferred to hospital to perform a bypass to the peroneal artery but failed.They are reported to still be in hospital.
Additional Manufacturer Narrative
(b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.The top-level assembly traveler was reviewed.There are no dda's, nce's or any other nonconformances related to this lot therefore supporting the device met material, assembly , and performance specifications.Case details were reviewed.Customer stated "left femoral angiogram was performed on a fragile 91-year-old that weighed 110lbs.The physician reported that there was no harm from the device.He was unable to advance the pronto v4 catheter into the vessel." no unit was returned to vsi/teleflex for evaluation.It is unknown if any damages were present on the unit.Additional information was requested.A response was received.There was no report of any visual defects of the pronto v4 catheter.There was no harm from the device.Physician was unable to advance via the vessels.Vessel factors such as calcification and tortuosity are unknown.No angiograms were provided.A bypass was attempted on the patient to the peroneal artery which was unsuccessful.A manufacturing record review was completed and no related nonconformances were found.It is unknown what could have caused the advancement issue of the pronto.Based on the limited information, the most likely root cause of the issue is undeterminable.

• Brand Name: PRONTO V4 5.5F
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17297224
• Report Number: 2134812-2023-00032
• Device Sequence Number: 19802177
• Product Code: QEZ
• UDI-Device Identifier: 10841156108977
• UDI-Public: 10841156108977
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K072810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: 03/14/2025
• Device Model Number: 4005
• Device Catalogue Number: 4005
• Device Lot Number: 723559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/10/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Female