MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MI,5FST,40CM,NIT/TUN7ECO; INTRODUCER, CATHETER

Catalog Number	7267V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "dr.Was using a micro puncture in femoral access case and the wire snapped when in use on patient".He was performing a fistulagram.The wire separated from the floppy end to the mandrel.They were having a hard time accessing into the fistula, they then tried to access from opposite end with wire-they believe the wire got caught in stent struts and they separated.They tried snaring the floppy end of wire that was left inside patient but were unable to retrieve it.They then used a biopsy access kit to get the wire out.They were able to complete the procedure with no issues, patient was in good condition.There was no patient harm and they were reported as fine.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "dr.Was using a micro puncture in femoral access case and the wire snapped when in use on patient".He was performing a fistulagram.The wire separated from the floppy end to the mandrel.They were having a hard time accessing into the fistula, they then tried to access from opposite end with wire-they believe the wire got caught in stent struts and they separated.They tried snaring the floppy end of wire that was left inside patient but were unable to retrieve it.They then used a biopsy access kit to get the wire out.They were able to complete the procedure with no issues, patient was in good condition.There was no patient harm and they were reported as fine.".
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only.Section d.4.-unique identifier (udi)# corrected to (b)(4).No return product evaluation could be completed as the device was not returned for investigation.Introducer guidewire is supplied by heraeus medical components.A device history record (dhr) review was completed.No issues or non-conformities were noted.Case details were reviewed.Customer stated, " dr.Was using a micro puncture in femoral access case and sheath snapped when in use on patient." no unit was returned to teleflex for evaluation.It is unknown what damages were present on the unit.Additional information was requested.A response was received.The defective part of the wire separating - it separated from the floppy end to the mandrel.Customer had a hard time accessing the fistula.An attempt was made from the opposite end and the wire is likely to have caught with the stent struts leading to separation.A biopsy access kit was used to get the wire out.No patient issues noted.The instructions for use (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.Based on the information, the most likely root cause of the issue is undeterminable.No risk evaluation required as the actual severity does not exceed the expected severity per the risk documentation.The der process will continue to monitor for any similar events.

• Brand Name: MI,5FST,40CM,NIT/TUN7ECO
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21409325
• Report Number: 2134812-2025-00005
• Device Sequence Number: 18469432
• Product Code: DYB
• UDI-Device Identifier: 10841156107079
• UDI-Public: (01)10841156107079(11)241028(17)271021(10)73K2400508(21)
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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 Catalogue Number: 7267V
• Device Lot Number: 73K2400508
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown