MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14402
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "after performing the puncture, when passing the guide thread, it stuck inside the needle.The guide wire just entered the tip and made memory.At the same moment, another catheter was opened and the passage was performed successfully"." the user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one image for analysis.Signs of use are visible; however, no obvious damage was noted.The needle involved with this complaint is not pictured.The customer returned one guide wire assembly for analysis.Signs of use were observed inside the green straightener tube.The needle involved with this complaint was not returned.Visual analysis of the guide wire revealed two distinct kinks and two offset coils towards the distal end.This resulted in the j-bend to be misshapen.Microscopic examination confirmed the damage and revealed that the distal and proximal welds are full and spherical.Visual analysis could not be performed on the needle as it was not returned for analysis.The kinks on the guide wire measured 435mm and 450mm from the proximal weld.The offsets measured 440mm and 441mm from the proximal weld.The guide wire length measured 17 7/8", which is within the specification limits of 11/16"-18 1/16" per the guide wire product drawing.The guide wire outer diameter measured 0.0175", which is within the specification limits of 0.0170"-0.0180" per the guide wire product drawing.The guide wire was inserted through a lab inventory 21ga introducer needle.Resistance was encountered at the location of the kinks/offsets; however, the guide wire was able to pass.All functional sections appeared to pass with little to no issue.Performed per ifu statement, "arrow advancer is used to straighten 'j' tip of guidewire for introduction of the guidewire into arrow raulerson syringe or a needle".Functional testing could not be performed on the actual needle involved with this complaint as it was not returned.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "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 of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed two kinks and two offsets towards the distal end.Despite the damage, the guide wire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, the observed damage appears consistent with undue force applied by the customer during use; however, this cannot be verified without the actual introducer needle also returned for analysis.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "after performing the puncture, when passing the guide thread, it stuck inside the needle.The guide wire just entered the tip and made memory.At the same moment, another catheter was opened and the passage was performed successfully"." the user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20179314
• Report Number: 9680794-2024-00874
• Device Sequence Number: 15519247
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: (01)00801902102140(11)230222(17)270930(10)14F23B0187(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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
• Device Catalogue Number: CS-14402
• Device Lot Number: 14F23B0187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown