MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VSI MICRO-INTRODUCER KITS; CATHETER

Model Number	7264V
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the physician was putting wire in through the needle and had difficulty.When he tried to pull the wire out he had difficulty and then wire was shredded.Additional information: during a peripheral angioplasty procedure, while gaining access in a heavily calcified femoral artery, the tip of the guidewire unravelled and separated.The guidewire was removed in its entirety.Another mik was opened to complete the procedure.No patient harm, injury or health consequence was reported.
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 physician was putting wire in through the needle and had difficulty.When he tried to pull the wire out he had difficulty and then wire was shredded.Additional information: during a peripheral angioplasty procedure, while gaining access in a heavily calcified femoral artery, the tip of the guidewire unravelled and separated.The guidewire was removed in its entirety.Another mik was opened to complete the procedure.No patient harm, injury or health consequence was reported.
Additional Manufacturer Narrative
(b)(4).One-unit of mik wire was returned to teleflex for evaluation.Minor blood particulates were noted on the unit.Approximately 4.5 cm of the distal tip was separated when compared to a good unit.Heraeus was notified of the complaint.A dhr review was completed.No issues or non-conformities were noted.Case details were reviewed.Customer stated "the physician was putting wire in through the needle and had difficulty.When he tried to pull the wire out, he had difficulty and then wire was shredded." the damages are likely to have occurred during use when operated against resistance.Per ifu - never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the guidewire against resistance may result in separation of the guidewire tip, damage to the guidewire, or vessel perforation.- do not withdraw the guidewire through the needle.If necessary, remove both the needle and guidewire as a unit to prevent the needle from damaging or shearing the guidewire.Additional information was requested.A response was received.Procedure was peripheral angioplasty.Vessel was heavily calcified.Guidewire was removed in its entirety.No harm or injury noted.It is likely that the wire was pulled against the calcified vessel or against the bevel of the needle leading to separation.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.

• Brand Name: VSI MICRO-INTRODUCER KITS
• 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: 17323426
• Report Number: 2134812-2023-00031
• Device Sequence Number: 20405833
• Product Code: DYB
• UDI-Device Identifier: 10841156107109
• UDI-Public: 10841156107109
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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 Model Number: 7264V
• Device Catalogue Number: 7264V
• Device Lot Number: 73M2200055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/14/2023
• 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 Age: 75 YR
• Patient Sex: Female