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

Model Number	5010
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	06/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been opened and a follow-up report will be submitted after investigation.
Event or Problem Description
As reported: in the pci procedure, the thrombus was at around proximal middle of lad, 6f, 3.0 guiding catheter, guide wire and 6fpronto lp were used to remove the thrombus.After the thrombus was extracted, on the device preparing table, the user just detached the syringe from the catheter and found the catheter shaft and y-adapter hub were separated.The pci procedure went fine and there was no impact to the patient.Additional information on 19jun2022: the device was completely out of the patient's vessel when the separation occurred.It was on the table that the user was about to filter the blood and thrombus.
Additional Manufacturer Narrative
One-unit of pronto lp was returned for evaluation.Minor blood particulates were noted.Shaft was noted to have multiple kinks on the proximal section.Hub separation was confirmed.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.A patient underwent a pci procedure for thrombus removal of the proximal lad vessel.The y connector hub separated from the shaft when the user detached the syringe.Additional information was requested.A response was received.The device was completely out of the patient when the separation occurred.The user was able to completely the case prior to this event.No issues noted while prepping the catheter for use before starting the procedure.

• Brand Name: PRONTO LP
• 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: 14983309
• Report Number: 2134812-2022-00039
• Device Sequence Number: 17386829
• Product Code: QEZ
• UDI-Device Identifier: 10841156100315
• UDI-Public: 10841156100315
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K072810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 10/12/2023
• Device Model Number: 5010
• Device Catalogue Number: 5010
• Device Lot Number: 713486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown