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

Model Number	7208V
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after investigation.
Event or Problem Description
It was reported that: during access by the physician, he was unable to advance the wire into the vessel to a depth he wanted.He attempted to remove the wire while the needle was still in place and encountered difficulty removing the wire.He increased the amount of force to remove the wire and noticed the wire was ""unraveled"".Fluoroscopy revealed a small piece of the wire tip in the wall of the vessel.Angiogram revealed normal flow in the vessel.The procedure was completed using a mik with a stiffen dilator.Patient was reported as fine post procedure.Additional information has been requested from the account.A follow up report will be submitted on receipt of this information.
Additional Manufacturer Narrative
(b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.A dhr review was completed by the supplier.All process steps were followed correctly.Case details were reviewed.Physician was unable to advance the wire into the vessel to its correct depth.He tried to remove the wire with the needle in place and encountered difficulty removing the wire.Physician noted the wire unravelled.A small piece of the wire was left in the vessel wall.No unit was returned to vsi/teleflex for evaluation.It is unknown if any other damages aside from separation were present.Additional information was requested.A response was received.No difficulty noted in accessing the vessel.Vessel was not calcified.Remainder of the device was discarded.Fluoroscopic pictures were shared.The piece was observed to be outside of the vessel likely in the subcutaneous tissue.Patient condition is fine.No medical intervention was employed.The damages are likely to have occurred during use in the procedure when operated against resistance.Per ifu states the following warning and precaution - 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.Per the intake information, customer removed the wire with intact needle.It is likely that the bevel of the needle could have interacted with the coil of the wire leading it to break.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.
Event or Problem Description
It was reported that: during access by the physician, he was unable to advance the wire into the vessel to a depth he wanted.He attempted to remove the wire while the needle was still in place and encountered difficulty removing the wire.He increased the amount of force to remove the wire and noticed the wire was ""unraveled"".Fluoroscopy revealed a small piece of the wire tip in the wall of the vessel.Angiogram revealed normal flow in the vessel.The procedure was completed using a mik with a stiffen dilator.Patient was reported as fine post procedure.Additional information has been requested from the account.A follow up report will be submitted on receipt of this information.

• Brand Name: MICRO-INTRODUCER KITS
• Common Device Name: INTORDUCER, CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16944354
• Report Number: 2134812-2023-00021
• Device Sequence Number: 13993639
• Product Code: DYB
• UDI-Device Identifier: 10841156107260
• UDI-Public: 10841156107260
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/26/2023

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: 10/28/2025
• Device Model Number: 7208V
• Device Catalogue Number: 7208V
• Device Lot Number: 73K2200695
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/22/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 56 KG