MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-27702-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the insertion, the doctor found the resistance, and then the swg was found kinked and can't use it.They changed a new one.No harm for the patient.The patient condition is fine.No medical intervention was required".
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "during the insertion, the doctor found the resistance, and then the swg was found kinked and can't use it.They changed a new one.No harm for the patient.The patient condition is fine.No medical intervention was required".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one guide wire.Signs of use were observed on the guide wire.Two kinks were observed along the guide wire body, and the distal j-bend appeared misshapen.Microscopic examination confirmed damage to the guide wire body.Both welds were present and appeared intact, full, and spherical.Two kinks were located at 150mm and 158mm from the distal end.The overall length of the guide wire measured 601 mm, which is within the specification limits of 596mm-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.802mm, which is within the specification limits of 0.788mm-0.826 mm per guide wire product drawing.The guide wire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user to "advance the guidewire into the arrow raulerson syringe approximately 10 cm until it passes through the syringe valves or into the introducer needle." the guide wire was advanced through a laboratory inventory arrow raulerson syringe (ars) and an 18g laboratory inventory introducer needle.Resistance was encountered at the location of the kinked area, and the guide wire could not be advanced through the ars or introducer needle at that point.The undamaged portions of the guide wire advanced with little to no resistance.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 instructions for use (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.Two kinks were observed along the guide wire body, and the distal j-bend was misshapen.The guidewire met all applicable dimensional requirements.Functional testing demonstrated resistance at the locations of the kinks, preventing advancement through the arrow raulerson syringe and introducer needle, while undamaged portions of the guide wire advanced with little to no resistance.A review of the device history record did not identify any manufacturing-related issues.Based on the condition of the guidewire and the report that the damage was observed during use, the likely root cause appears consistent with unintentional use error.Teleflex will continue to monitor and trend reports of this nature.
Event or Problem Description
It was reported that "during the insertion, the doctor found the resistance, and then the swg was found kinked and can't use it.They changed a new one.No harm for the patient.The patient condition is fine.No medical intervention was required".

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 23596890
• Report Number: 3006425876-2025-01074
• Device Sequence Number: 21427609
• Product Code: FOZ
• UDI-Device Identifier: 00801902102362
• UDI-Public: (01)00801902102362(11)241003(17)260912(10)71F24J1433(21)
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2025

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: 09/12/2026
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F24J1433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 01/26/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/19/2025; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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.; N/A.
• Patient Sex: Unknown