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

Model Number 7256V

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/03/2022

Event Type  Injury  

Event Description

As reported: during pci stent placement the micropuncture wire was retained overlying or perhaps within the left common femoral artery and appeared to tangle within the knot overlying the left cfa.Then they were unsuccessful in removing the wire.Patient had an infection in groin.Patient went to or next day for removal of the micro puncture wire which was successfully removed.

Manufacturer Narrative

An investigation has been opened and 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.There was no lot number provided for this complaint.Therefore, no record review could be completed case details were reviewed.The mik wire was retained within the left common femoral artery and appeared to tangle within the knot.No unit was returned to vsi/teleflex for evaluation.It is unknown what damages could have occurred on the wire.Ifu was reviewed.The following warnings and precautions were 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.Also, access site complications is identified as a potential adverse effect that maybe associated with vsi mik kit.It is unknown if the wire was operated against resistance or wire was withdrawn through the needle.Additional information was requested from the account.A response was received.Product will not be returned.No lot number was provided.Mik broke off and tangled within the patient.Patient was sent to the or next day to remove the wire which was successful.Based on the information, 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: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564300
• MDR Report Key: 13911545
• MDR Text Key: 288601103
• Report Number: 2134812-2022-00025
• Device Sequence Number: 1
• Product Code: DYB
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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
• Device Operator: Other
• Device Model Number: 7256V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 03/07/2022
• Supplement Dates FDA Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female