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

Model Number	5010
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, about 5-6 inches of it broke off while doing an intervention, but thankfully we were able to retrieve the entire component that detached itself.Additional information stated that procedure was completed with a different device.
Additional Manufacturer Narrative
A review of device history records will be conducted.A follow-up report will be issued after the investigation is complete.
Additional Manufacturer Narrative
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.Patient underwent a procedure.Pronto catheter was used.5-6 inches of it broke while doing an intervention.It is unknown what type of damages occurred on the shaft.Per ifu, the following was identified 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.Additional information was requested.No response was received.No pictures or angiographic videos of the issue were shared.No procedural noted were provided.Based on the limited information, the most likely root cause of the issue is undeterminable.

• 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: marling heaton ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 14776231
• Report Number: 2134812-2022-00035
• Device Sequence Number: 14660848
• Product Code: QEZ
• UDI-Device Identifier: 10841156100315
• UDI-Public: (01)10841156100315(17)230129(10)706056
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: Other
• Device Expiration Date: 01/29/2023
• Device Model Number: 5010
• Device Catalogue Number: 5010
• Device Lot Number: 706056
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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
• Patient Sex: Unknown