MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 5 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-12402
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during cvc insertion outer sheet of guide wire broke and wire unraveled.All pieces intact and able to remove wire from patient." a hematoma resulted from the occurrence.Manual pressure was applied and a new line was inserted.It was reported "the patient remains in the icu for illness unrelated to the broke wire issue".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one guidewire for analysis.Signs of use in the form of biomaterial were observed on the returned component.Visual examination revealed the guidewire was unraveled from the distal end.There was also one kink in the guidewire body.The distal j-bend was intact but slightly misshapen.The spring coil was still attached at the proximal end.Microscopic examination of the guidewire confirmed that the core wire was broken adjacent to the distal weld.The exposed distal core wire tip was tapered at the point of separation.Both welds were present and appeared full and spherical.The proximal weld was still intact.The kink in the guidewire body measured at 356mm from the proximal end.The overall length of the broken core wire measured 452mm, which is within the specification limits of 449.2mm - 458.8mm per the guidewire product drawing; therefore, no pieces of the core wire were missing.The outer diameter of the guidewire measured 0.44mm, which is within the specification limits of 0.432mm - 0.457mm per the guidewire product drawing.Functional testing was not able to be performed due to the nature of the damage.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed, and no relevant manufacturing issues were identified.The instructions for use (ifu) provided with this product warns 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.Warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report that the guidewire unraveled during use was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guidewire met all relevant 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 2.0 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire 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 caused or contributed to this event.Teleflex will continue to monitor and trend reports of this nature.
Event or Problem Description
It was reported "during cvc insertion outer sheet of guide wire broke and wire unraveled.All pieces intact and able to remove wire from patient." a hematoma resulted from the occurrence.Manual pressure was applied and a new line was inserted.It was reported "the patient remains in the icu for illness unrelated to the broke wire issue".

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 5 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: 22003704
• Report Number: 9680794-2025-00414
• Device Sequence Number: 7266604
• Product Code: DQY
• UDI-Device Identifier: 30801902124310
• UDI-Public: (01)30801902124310(11)250128(17)281130(10)14F25A0111(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: CS-12402
• Device Lot Number: 14F25A0111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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.; NOT REPORTED.
• Patient Sex: Unknown