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

Model Number	4006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	09/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not 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: pronto was used in heavily calcified peripheral artery.Pronto tip "broke off" during withdrawal.Had to use a snare to capture the severed pronto tip.Patient brought back 3 days later for thrombectomy and embolectomy.Improving but guarded condition.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.An image was sent by the account.A manufacturing record review was completed and no onconformances were related to this lot therefore, supporting the device met material, assembly and performance specifications.The tip appears to be intact however, the separation of the shaft of the catheter which is significantly faraway from the tip.Case details were reviewed.A patient underwent a thrombus extraction in peripheral artery.The event description states pronto was used in a heavily calcified artery.Tip broke off during withdrawal.Additional information was requested from the account.A response was received.The artery in which the catheter was used was sfa and popliteal artery.Per ifu pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary vasculature.The following warning and precaution were noted never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, damage to the catheter, or vessel perforation exercise care in handling of the catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking.It is unknown if the distal tip experienced resistance when used against a calcified artery causing separation.The tip was snared out successfully.The procedure outcome was extensive distal embolization.Ifu states embolism is a potential adverse effect that may be associated with the pronto v4 extraction catheter.Patient was brought back after 3 days for a thrombectomy and embolectomy procedure.The patient condition is improving and fine.

• Brand Name: PRONTO V4
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564300
• MDR Report Key: 12703557
• Report Number: 2134812-2021-00069
• Device Sequence Number: 11915668
• Product Code: DXE
• UDI-Device Identifier: 30841156100234
• UDI-Public: 30841156100234
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K103405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: 4006
• Device Lot Number: 708916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Unknown
• Patient Weight: 64 KG