MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC MICRO-INTRODUCER KIT; CATHETER

Model Number	7264V
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been opened to review device history record and risk documentation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Distal coil of mik wire unraveled.Additional information on 17aug2022: the account reported nothing was left in the patient, and the patient is fine.After multiple good faith attempts, the account would not release any additional information or respond to the requested questions.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.Introducer wire packed in the mik kit is a supplied component by a third-party supplier.A device history record review was requested for the wire lots packed in the mik lot.No issues or non-conformances noted by the third-party supplier.All process steps were performed correctly.Case details were reviewed.It is unknown what degree of damages have occurred on the shaft of the wire.Per ifu the following warning and precaution was identified: 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.Patient condition is fine.No parts of the wire were left in the patient.No response was received on other questions related to the procedure or use of the wire.No pictures of the issue were provided.Based on the information, the most likely root cause of the issue is undeterminable.

• Brand Name: MICRO-INTRODUCER KIT
• 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: angela meister ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564253
• MDR Report Key: 15263248
• Report Number: 2134812-2022-00050
• Device Sequence Number: 5977216
• Product Code: DYB
• UDI-Device Identifier: 10841156107109
• UDI-Public: 10841156107109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 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): 08/03/2022

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: 03/11/2025
• Device Model Number: 7264V
• Device Catalogue Number: 7264V
• Device Lot Number: 73C2200198
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/20/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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