MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 2-LUMEN 5 FR X 5 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	AK-22502
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "dr.Started a central line in right internal jugular when he removed the wire it came out curled and the catheter was unable to aspirate.This resulted in dr.To have to place a second central line in the right internal jugular after removing the first attempt." no patient injury reported.
Event or Problem Description
The complaint is reported as: "dr.Started a central line in right internal jugular when he removed the wire it came out curled and the catheter was unable to aspirate.This resulted in dr.To have to place a second central line in the right internal jugular after removing the first attempt." no patient injury reported.
Additional Manufacturer Narrative
Qn#(b)(4).The report that the guide wire kinked during use was confirmed through examination of the returned sample.The customer returned a single nitinol guide wire and a 2-lumen cvc for analysis.Signs-of-use were observed on the guide wire and catheter.Visual analysis revealed that the guide wire contained one major kink and one long continuous bend towards the distal end.Despite the damage, the distal j-bend was intact.Microscopic examination confirmed the kinks and revealed that the distal and proximal weld were full and spherical.The kinks in the guide wire were located 31mm via calibrated ruler from the distal weld.The long continuous bend measured approximately 55mm-100mm via calibrated ruler from the distal weld.The overall length of the guide wire measured 45.4cm via calibrated ruler, which was within the specification of 43.75cm-46.25cm per the guide wire product drawing.The outer diameter (od) of the guide wire measured 0.524mm via calibrated micrometer, which was within the specification of 0.510mm-0.551mm per the guide wire product drawing.The guide wire was advanced through the returned cvc.Despite the damage, the guide wire was able to pass with little to no issue.Performed per ifu statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".A manual tug test confirmed that both the distal and proximal welds were intact.The ifu provided with the kit informs 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".A device history record review was performed, and no relevant findings were identified.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC KIT: 2-LUMEN 5 FR X 5 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17807719
• Report Number: 9680794-2023-00690
• Device Sequence Number: 6727915
• Product Code: FOZ
• UDI-Device Identifier: 10801902122305
• UDI-Public: 10801902122305
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (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): 08/29/2023

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: 02/17/2024
• Device Catalogue Number: AK-22502
• Device Lot Number: 13F22H0289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• 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