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

Model Number	7272V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(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: "wires separated.Qty of 2." associated to another complaint.Additional information on 22feb2023: the complaint was on two wires of the same lot number of the micropuncture kits.There were no adverse effects to patient mentioned in phone call.Several attempts to gain more information from the account have been unsuccessful.A follow up report will be submitted if more information becomes available.
Additional Manufacturer Narrative
(b)(4).Associated with mdr 2134812-2023-00010.There was no product returned for this complaint.No returned product evaluation could be completed.Mik introducer wire is a supplied unit by heraeus medical.A device history record review was completed for the wire lot.All process steps were followed correctly.Case details were reviewed.Customer stated, "wire separated".No unit was returned to vsi/teleflex for evaluation.It is unknown what damages occurred on the unit and where exactly the separation was noted.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.Additional information was requested.No response was received.It is unknown if any piece was left in the anatomy, or any interventional procedure was employed to treat or remove the separated piece.Customer stated no adverse effects were noted on the patient.A manufacturing record review was completed by heraeus and no related nonconformances were found.The occurrence for similar issues was calculated and found to be 0.0011% for which it is rated as very low and improbable per heraeus.It is likely that the bevel of the needle could have interacted with the coil leading to the separation when operated against resistance.However, without additional information and confirmation from the customer, the most likely root cause of the issue is undeterminable.
Event or Problem Description
It was reported that: "wires separated.Qty of 2." associated to another complaint.Additional information on 22feb2023: the complaint was on two wires of the same lot number of the micropuncture kits.There were no adverse effects to patient mentioned in phone call.Several attempts to gain more information from the account have been unsuccessful.A follow up report will be submitted if more information becomes available.

• Brand Name: MICRO-INTRODUCER KIT
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16501832
• Report Number: 2134812-2023-00010
• Device Sequence Number: 15017490
• Product Code: DYB
• UDI-Device Identifier: 10841156107031
• UDI-Public: 10841156107031
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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: 07/22/2025
• Device Model Number: 7272V
• Device Catalogue Number: 7272V
• Device Lot Number: 73G2200539
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/19/2023
• 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
• Patient Sex: Unknown