MAUDE Adverse Event Report: ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CS-24301-E
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The spring wire guide was found kinked during puncture on the patient.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
The spring wire guide was found kinked during puncture on the patient.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one cvc kit containing a spring wire guide (swg), arrow raulerson syringe (ars), s-l catheter, dilator, 18 ga introducer needle, and catheter/needle assembly for evaluation.Visual inspection of the swg did not reveal any kinks or bends.The j-bend was intact.Microscopic examination confirmed both welds were attached and fully spherical.The overall length of the guide wire measured 602 mm which is within the specification of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.801 mm which is within the specification of 0.788-0.826 mm per guide wire product drawing.The guide wire was advanced through the returned ars and a lab inventory 18ga introducer needle per the instructions-for-use (ifu).The ifu provided with this kit states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire passed through both components with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The ifu provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the report that the guide wire kinked during use was not able to be confirmed through examination of the returned sample.No damage was found on the returned guide wire.The returned guide wire met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire returned, no problem was found on the sample.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• MDR Report Key: 12350953
• Report Number: 3006425876-2021-00774
• Device Sequence Number: 14750033
• Product Code: FOZ
• UDI-Device Identifier: 50801902043912
• UDI-Public: 50801902043912
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: No Information
• Device Expiration Date: 07/03/2022
• Device Catalogue Number: CS-24301-E
• Device Lot Number: 71F20G0758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2020
• 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