MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN038301
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: catheter was used for emergency dialysis for hyperkalemia and metabolized acidosis.The guidewire unraveled during removal at the end of cvc insertion, with suspicion of embolization of a portion of the guidewire into the patient's systemic circulation." an echocardiogram confirmed that none of the guidewire remained inside the patient.There was no patient harm or injury.The patient had good clinical progress in the days following the procedure.
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire for evaluation.The guidewire was unraveled and showed definite signs of use.Visual analysis showed that the unraveling occurred toward the distal end, with multiple kinks present along the body.The distal end of the core wire was exposed beyond the coil wire, and the distal weld was absent on both the core wire and the coil wire and was not returned.Microscopic inspection confirmed that the distal end of the exposed core wire was tapered at the point of separation.The proximal weld was intact and appeared full and spherical.Visual analysis of the catheter could not be performed because it was not returned.The kinks in the guidewire measured 22mm, 230mm, and 375mm from the proximal end.The broken core wire measured 598mm in length, which is within the specification limits of 596mm - 604mm per the guidewire product drawing which indicates that the core wire broken directly adjacent to the distal weld.The outer diameter of the guidewire measured 0.85mm, which is within the specification limits of 0.838mm - 0.877mm per the guidewire product drawing.Functional inspection of the guidewire could not be performed due to the damage to the returned guidewire.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this product 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 guidewire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal end, however, the separated portion was not returned.The guidewire met all dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guidewires 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 guidewire kinking.Guidewire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely contributed to this event; however, the probable cause could not be determined based upon the information provided and without the catheter and separated portion of the guidewire returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: catheter was used for emergency dialysis for hyperkalemia and metabolized acidosis.The guidewire unraveled during removal at the end of cvc insertion, with suspicion of embolization of a portion of the guidewire into the patient's systemic circulation." an echocardiogram confirmed that none of the guidewire remained inside the patient.There was no patient harm or injury.The patient had good clinical progress in the days following the procedure.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 24079408
• Report Number: 3006425876-2026-00096
• Device Sequence Number: 15891763
• Product Code: DQY
• UDI-Device Identifier: 00801902102119
• UDI-Public: (01)00801902102119(11)200827(17)250801(10)71F20H2540(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/17/2025

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: 08/01/2025
• Device Model Number: IPN038301
• Device Catalogue Number: CS-12123-F
• Device Lot Number: 71F20H2540
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• 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