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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not returned for evaluation and an investigation has been opened to review device and history records, risk documentation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: pronto catheter tip broke off during the procedure.Multiple attempts were made to receive additional information: information received from site: at this time, i am only allowed to inform you that the tip of the catheter did break off during a procedure.Procedure outcome is unknown, and if medical intervention was required is also unknown.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.The lot manufactruing records were reviewed.There are no nonconformances related to this lot therefore, supporting the device met material, assembly and performance specifications.The event description states that the pronto catheter tip broke off during the procedure.No product was returned for evaluation.It is undeterminable what type of damages could have occurred with the shaft of the catheter.It is unknown how much of the tip separated and if the tip was left in the patient or retrieved using another procedure.Per ifu states the following warning and precaution.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 catheter was manipulated against resistance causing damages.Additional information was requested from the account.No response as received.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue is undeterminable.

• Brand Name: PRONTO V4
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 12060042
• Report Number: 2134812-2021-00046
• Device Sequence Number: 4013770
• Product Code: DXE
• UDI-Device Identifier: 30841156100234
• UDI-Public: (01)30841156100234
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: 09/15/2022
• Device Model Number: 4006
• Device Lot Number: 680653
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1