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

Model Number	7274V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/10/2021
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: in the process of getting more information.Cath lab manager sent email stating "we had a micro-introducer shear off into a patient's artery this week.I have retained the piece of the introducer that came out and the packaging.We did send the patient to have the other piece surgically removed." additional information received 27dec2021: physician stated: it was not the fault of our micro introducer kit as it was used on a patient that knowing had very fibrotic tissue which caused the malfunction.In hindsight, he stated that it would have been better to not use the mik and to have a vascular surgeon cut down for access.When the patient was sent to surgery to have the remaining piece removed, physician stated that the surgeon was amazed at how fibrotic the tissue was and would need to be removed before the could access the vessel.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.A manufacturing record review was completed by tecate and no related nonconformances were found.The event description states mik sheath sheared off in the patient's artery.It is unknown what damages occurred and how much of the sheath was sheared off.Additional information was requested from the account.A response was received.Physician stated that the issue was not related to the mik as it was used in a patient with a very fibrotic tissue.Patient was sent to have the piece surgically removed.Surgeon remarked that the tissue was very fibrotic.Fibrosis refers to excessive deposition of collagen and ecm proteins in the blood vessel (1).This leads to scarring of the tissue.This is likely due to anatomical factors, the sheath used could have been manipulated against resistance leading to separation.Per ifu it 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.Physician also mentions that it would have been better to not use mik and may have proceeded with cut down for access.

• 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: 13171781
• Report Number: 2134812-2022-00004
• Device Sequence Number: 14701985
• Product Code: DYB
• UDI-Device Identifier: 20841156106994
• UDI-Public: 20841156106994
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2024
• Device Model Number: 7274V
• Device Lot Number: 73E2100494
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Sex: Unknown