MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CA-22123-F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: during advancement of the trialysis line resistance was felt and the wire snapped within the infusion lumen.The wire snapped outside spring 6 cm down the wire.The dialysis line was removed, and the wire was clamped with a forceps and removed.X-ray confirmed that there was no portion of the wire retained in the patient.The patient was reported as stable post the procedure.
Event or Problem Description
It was reported that: during advancement of the trialysis line resistance was felt and the wire snapped within the infusion lumen.The wire snapped outside spring 6 cm down the wire.The dialysis line was removed, and the wire was clamped with a forceps and removed.X-ray confirmed that there was no portion of the wire retained in the patient.The patient was reported as stable post the procedure.
Additional Manufacturer Narrative
(b)(4).The customer returned a guide wire and lidstock for evaluation.No obvious signs of use were observed.Visual examination revealed the guide wire is unraveled/separated from the proximal end.It was observed that the core wire was severed in two locations while the coil wire was separated in one location.Microscopic examination confirmed the separations and revealed that the distal and proximal welds were full and spherical.Further analysis revealed that the core wire severed directly adjacent to the proximal weld.The total length of the severed core wire measured 597mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.85mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.Functional testing could not be performed due to the severity of the damage to the returned sample.A manual tug test confirmed that the distal weld was 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 that the guide wire separated was confirmed through examination of the returned sample.The core wire was broken in two locations.Once adjacent to the proximal weld and once around the middle of the extrusion.The coil wire was also severed.Despite the damage, the guide wire met all dimensional requirements.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, 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: 3-LUMEN 12 FR X 16 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18109884
• Report Number: 9680794-2023-00837
• Device Sequence Number: 12119698
• Product Code: FOZ
• UDI-Device Identifier: 00801902007834
• UDI-Public: 00801902007834
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/16/2023

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
• Device Expiration Date: 12/21/2024
• Device Catalogue Number: CA-22123-F
• Device Lot Number: 33F23B0065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown