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

Model Number 7267V

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/22/2022

Event Type  Injury  

Event Description

As reported: wire embedded in tissue or plaque.Additional information from medwatch (mw5106388) was received on 01feb2022 - tip of introducer broke off during insertion and became embedded in wall of left femoral artery.Fda safety report id# (b)(4).

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.

Manufacturer Narrative

There was no product returned for this complaint.No returned product evaluation could be completed.A device history review was completed no nonconformances were noted.All processes were followed correctly.The event description states wire embedded in tissue or plaque.No unit was returned for evaluation.It is unknown if any damages were present on the shaft of the guidewire.The medwatch report (mw5106388) was reviewed.The event details states that the "tip of the introducer broke off during insertion and became embedded in the wall of the left femoral artery".Additional information was requested from the account.No response was received.Clarification on event details was not provided by the account.No procedural notes, surgical notes, images and or angiograms was provided.Procedure outcome and patient condition post procedure is unknown.It is unknown if the wire was operated against resistance and/or if it was withdrawn through the needle.Per ifu it states the following warning and precaution: - never advance or withdraw an intravascular device against resistance until the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.Based on the limited information and no product evaluation, the most likely root cause of the issue is undeterminable.

• Brand Name: MICRO-INTRODUCER KIT
• Type of Device: 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: 13604342
• MDR Text Key: 290267104
• Report Number: 2134812-2022-00023
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 20841156107076
• UDI-Public: 20841156107076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2024
• Device Model Number: 7267V
• Device Lot Number: 73B2100222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention