MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 5.5 FR X 8 CM; CATHETER PERCUTANEOUS

Model Number	IPN918853
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during cvc insertion in right femoral on 1 year old baby, it was observed that the swg kinked 90 degrees when the introducing the dilator.The swg was already in place and confirmed via echography.This happened twice with this patient on the same day with the same lot number.It was not possible to reinsert new cvc in the same insertion site as hematoma appeared.A new cvc was inserted in the left femoral.As a result, it prolonged the sedation time with hemorrhagic and infection risk for the baby".
Additional Manufacturer Narrative
(b)(4).Additional information received 23-dec-2024 indicates the spring wire guide was "not frayed and removed in its entirety".It was also reported that the current condition of the patient was "fine".The customer returned one swg for evaluation.The guidewire showed evidence of use.The dilator was not returned.The guidewire was observed to have one kink on the body with offset coils.The distal j-bend was not misshapen and was intact.Microscopic examination confirmed the kink in the guidewire body.Both welds were present and were observed to be full and spherical.The kink in the guidewire was located 189mm from the proximal tip.The overall length of the guidewire measured 454mm which is within the specifications of 449.2mm - 458.8mm per guidewire product drawing.The outer diameter of the guidewire measured 0.44mm, which is within the specifications of 0.432mm - 0.457mm per guidewire product drawing.The guidewire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guidewire.Resistance was met at the kinked locations; however, the undamaged portions of the guidewire passed through both components with minimal resistance.Performed per the instructions for use (ifu) statement, "advance guidewire into arrow raulerson syringe approximately 10cm until it passes through syringe valves or into introducer needle." functional inspections of the dilator could not be performed as the dilator was not returned.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution, "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 guidewire kinked during use was confirmed through examination of the returned sample.The guide wire had a kink on the body.The returned guidewire met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional user error likely contributed to this event, however, the probable cause of guidewire and dilator resistance could not be determined based upon the information provided and without the dilator being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during cvc insertion in right femoral on 1 year old baby, it was observed that the swg kinked 90 degrees when the introducing the dilator.The swg was already in place and confirmed via echography.This happened twice with this patient on the same day with the same lot number.It was not possible to reinsert new cvc in the same insertion site as hematoma appeared.A new cvc was inserted in the left femoral.As a result, it prolonged the sedation time with hemorrhagic and infection risk for the baby".

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 FR X 8 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20964920
• Report Number: 3006425876-2024-01234
• Device Sequence Number: 4033149
• Product Code: DQY
• UDI-Device Identifier: 30801929122979
• UDI-Public: (01)30801929122979(11)230926(17)280731(10)71F23H0899(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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 Model Number: IPN918853
• Device Catalogue Number: CS-15553-E
• Device Lot Number: 71F23H0899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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: N/A.; N/A.
• Patient Age: 12 MO
• Patient Sex: Unknown