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

Catalog Number	CV-17702-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "at the moment of passage of the right subclavian double-lumen central catheter, there is no return of the catheter guide, as evidenced by x-ray and ultrasound, which show it coiled around an unknown object." additional information received states "at the end of the guide passage, it is found to be dysfunctional, catheter placement attempted using the seldinger technique, not possible, finally, attempt to remove the guide is unsuccessful due to great resistance.A right jugular catheter is inserted guided by ultrasound, with a single puncture using the seldinger technique without complications.An x-ray is taken, showing evidence of a knot-shaped guide.The hemodynamics service is called, which indicates that a vascular study should be performed and the position of the guide should be verified".Endovascular removal of intravascular foreign body was performed by in terventional radiology on (b)(6) 2025.There was no patient harm or injury.The patient's current condition is reported as "unknown".
Event or Problem Description
It was reported that "at the moment of passage of the right subclavian double-lumen central catheter, there is no return of the catheter guide, as evidenced by x-ray and ultrasound, which show it coiled around an unknown object." additional information received states "at the end of the guide passage, it is found to be dysfunctional, catheter placement attempted using the seldinger technique, not possible, finally, attempt to remove the guide is unsuccessful due to great resistance.A right jugular catheter is inserted guided by ultrasound, with a single puncture using the seldinger technique without complications.An x-ray is taken, showing evidence of a knot-shaped guide.The hemodynamics service is called, which indicates that a vascular study should be performed and the position of the guide should be verified".Endovascular removal of intravascular foreign body was performed by in terventional radiology on 12/10/2025.There was no patient harm or injury.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided three photos for analysis.The photos show an x-ray image of the guide wire knotting within the right subclavian vasculature.No photos showing the guide wire separation were provided.A complete visual inspection could not be performed as no sample was returned for analysis.Additional information from the customer stated that the guide wire had knotted and then separated within the right subclavian vasculature which required surgical consult and additional imaging.Clinical and medical affairs (cma) was consulted, and they stated that since the customer reported using the seldinger technique under the clavicle, the needle bevel would need to be turned downward to direct the guidewire downward.The guidewire will encounter obstruction within the patient anatomy at the clavicle.The condition of the guidewire in the x-ray image is consistent with the technician repeatedly retracting and pushing the guidewire downward, resulting in knotting.However, without the sample received, the root cause cannot be determined.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "precaution: if resistance is encountered when attempting to remove guidewire after catheter placement, guidewire may be kinked around tip of catheter within vessel.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 customer report of the guide wire knotting within the patient was confirmed by visual inspection of the customer supplied photos.The photos show an x-ray image of the guide wire knotting within the right subclavian vasculature.Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 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: 23943132
• Report Number: 9680794-2026-00004
• Device Sequence Number: 10684060
• Product Code: DQY
• UDI-Device Identifier: 10801902183771
• UDI-Public: (01)10801902183771(11)250324(17)300228(10)14F25B0291(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 14F25B0291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2025
• 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.
• Patient Age: 63 YR
• Patient Sex: Male