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

Catalog Number	7267V
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "patient under going permacath placement on extremity that had previous catheter placements.The provider noted that the vein was occluded and tried to push pass the occlusion in an effort to ensure patient did not lose placement in extremity.He was unable to to pass occlusion and withdrew guide wire.Once withdrawn it was noted that tip of wire broke.Contrast visualization was performed to verify occlusion and location of tip of wire.It was determined that vein was occluded without further use and that tip was in a location that it would not move or cause harm." the current condition of the patient is "unknown" at this time.
Additional Manufacturer Narrative
Qn# (b)(4).No product evaluation could be completed as no product was returned for the investigation.A lot number was not provided by the customer, therefore, lot traceability to the heraeus wire could not be performed.Case details were reviewed.It is unknown how much of the distal tip wire separated.It is unknown if the wire was passed through the needle.The ifu states the following warning: - 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, the most likely root cause of the issue is undeterminable.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported "patient under going permacath placement on extremity that had previous catheter placements.The provider noted that the vein was occluded and tried to push pass the occlusion in an effort to ensure patient did not lose placement in extremity.He was unable to pass occlusion and withdrew guide wire.Once withdrawn it was noted that tip of wire broke.Contrast visualization was performed to verify occlusion and location of tip of wire.It was determined that vein was occluded without further use and that tip was in a location that it would not move or cause harm." the current condition of the patient is "unknown" at this time.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19220188
• Report Number: 2134812-2024-00017
• Device Sequence Number: 12788568
• Product Code: DYB
• UDI-Device Identifier: 10841156102920
• UDI-Public: 10841156102920
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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: UNKNOWN
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown