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

Model Number	7267V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2022
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 via voluntary medwatch 5108981.During use on a patient: teleflex stiffen micro-introducer wire being used during a cardiac catheterization became lodged in the distal abdominal aorta.During removal of the lodged wire, a 12-15cm piece of the wire broke off the introducer and was unable to be removed.Additional information received on (b)(6) 2022: teleflex stiffen micro-introducer wire being used during a cardiac catherization became logged in the distal abdominal aorta.During removal of the logged wire a 12-15cm piece of the wire broke off of the introducer and was unable to be removed.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.The supplier for introducer guidewires was notified.A device history record review was requested.All processes were followed, and no non-conformances were noted.Case details were reviewed.A micro introducer kit (mik) guidewire used in cardiac catherization became lodged in the abdominal aorta.12-15 cm of the wire broke off.It is unknown what other damages could have occurred on the shaft and/or if the wire was unraveled.No angiograms or imaging was shared.Ifu was reviewed, and the following was noted: 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 from the account.No response was received.Anatomical factors of the vessel are unknown.Procedure outcome is unknown.It is unknown if the wire was operated against resistance or wire was withdrawn through the needle.Based on the information, the most likely root cause of the issue is undeterminable.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: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564300
• MDR Report Key: 14459389
• Report Number: 2134812-2022-00030
• Device Sequence Number: 4597041
• Product Code: DYB
• UDI-Device Identifier: 10841156107079
• UDI-Public: 10841156107079
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: 11/25/2024
• Device Model Number: 7267V
• Device Catalogue Number: 7267V
• Device Lot Number: 73L2100779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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: Other
• Patient Sex: Unknown