MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VSI MICRO-INTRODUCER KITS MI,5F,40CM,NIT/TUN7C; INTORDUCER, CATHETER

Model Number	7250V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#:(b)(4).An investigaion 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: abscess drainage on patient was being performed and in the initial access, a piece of the wire tip broke off and was left in the patient.Additional information has been requested from the account and a follow up report will be submitted on receipt of this info.
Event or Problem Description
It was reported that: abscess drainage on patient was being performed and in the initial access, a piece of the wire tip broke off and was left in the patient.Additional information has been requested from the account and a follow up report will be submitted on receipt of this info.
Additional Manufacturer Narrative
Qn#(b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.The supplier for introducer wires was informed.A dhr review was completed.All processes were followed correctly.No non-conformances were noted.Case details were reviewed.Customer stated a piece of wire tip broke off and left in the patient.No unit was returned to vsi/teleflex for evaluation.It is unknown what damages were incurred on the mik wire and how much of the tip was separated.Additional information was requested.No response was received.A manufacturing record review was completed by the supplier and no related nonconformances were found.Based on the limited information, the most likely root cause of the issue is undeterminable.

• Brand Name: VSI MICRO-INTRODUCER KITS MI,5F,40CM,NIT/TUN7C
• 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: 16960144
• Report Number: 2134812-2023-00024
• Device Sequence Number: 5392277
• Product Code: DYB
• UDI-Device Identifier: 10841156107192
• UDI-Public: 10841156107192
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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: 07/06/2024
• Device Model Number: 7250V
• Device Catalogue Number: 7250V
• Device Lot Number: 73J2100779
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/30/2023
• 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 Sex: Unknown