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

Model Number	7250V
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: a 5fr micro- introducer was used for a vascular access right femoral vein.The wire would not advance through the needle.Physician pulled both wire and needle out.The wire stretched, and the tip of the wire broke off.We checked under fluoroscopy and the tip was in the right groin.Physician stated the wire was extravascular and would follow up with the patient.The exam was completed without any further incident.No medical intervention was required.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.Case details were reviewed.The supplier was notified, and a review was requested.A manufacturing record review was completed and no related nonconformances were found.No product was returned to vsi/teleflex for investigation.A returned product evaluation was not completed.It is likely that the guidewire could have been operated against resistance.Per ifu: "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".No procedure details were provided to confirm this outcome.It is unknown if any other damages were present on the guidewire.Additional information was requested from the account.No response was received.It is unknown if the tip was retrieved or a procedure will be performed on a later date to remove it.Based on the limited information and no product evaluation, 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
• MDR Report Key: 10971782
• Report Number: 2134812-2020-00097
• Device Sequence Number: 14517713
• Product Code: DYB
• UDI-Device Identifier: 10841156102791
• UDI-Public: (01)10841156102791
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2020
• Device Model Number: 7250V
• Device Catalogue Number: 7250V
• Device Lot Number: 671954
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1