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

Model Number	7262V
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been opened and a follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: brachial artery access, physician stuck with the needle and delivered the micro wire and had resistance.While removing the wire, the wound tip unraveled.Pulled the needle out of the body and still had to remove more wound tip of wire but it all came out.The needle seemed to have been inserted more into the vessel after the wire met resistance as the wire has an acute bend at the distal tip like the needle pinched/kinked it disallowing it to be withdrawn smoothly.The patient is fine, no complications from the device.
Additional Manufacturer Narrative
One unit of mik introducer wire along with the needle was returned for evaluation.Blood particulates were noted on the product.Unit was decontaminated and inspected.The coil was unraveled from the core wire.The coil was also kinked and stretched.A manufacturing record review was completed by the supplier, and no related non-conformance's were found.Case details were reviewed.A patient underwent a procedure for which a brachial artery access was performed.The physician used an echogenic needle to deliver a wire and had resistance.While removing the wire the tip unraveled.One unit of introducer wire attached to the needle was returned.The weld dome section of the wire was caught with the needle due to the damages.The coil had unraveled and stretched from the core wire.Kinks on the core wire were also observed.Per ifu, states the following warning - 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.Additional information was requested from the account.A response was received.Vessel was not damaged.It is unknown why the wire met resistance upon insertion even with ultrasound used as a means for access.Account stated that the needle seemed to have inserted more into the vessel after the wire met resistance.The wire had an acute bend which is pinched/kinked thereby not allowing it to be withdrawn smoothly.Per ifu, states the following precaution - 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.Access vessel anatomical factors such as calcification and tortuosity are unknown.It is likely that the wire interacted with the needle incurring damage causing it to unravel during withdrawal.The physician pulled the needle out of the body and removed all the wire out.Procedure was completed using another mik from the same lot without any issues based on the information, the most likely root cause of the issue is operational context and/or unintended use error.

• 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: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564300
• MDR Report Key: 12703923
• Report Number: 2134812-2021-00070
• Device Sequence Number: 6243515
• Product Code: DYB
• UDI-Device Identifier: 20841156107120
• UDI-Public: 20841156107120
• 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): 09/29/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: 7262V
• Device Lot Number: 73C2100337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 72 KG