MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 12" (30 CM); CATHETER PERCUTANEOUS

Catalog Number	CS-04400
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "the swg was unable to pass through the dilator during the procedure because of resistance.Therefore, the kit was replaced with a new kit to complete the procedure.No injury to the patient occurred." additional information received states "there was a burr like deformation near the hub on the dilator".There was no medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the swg was unable to pass through the dilator during the procedure because of resistance.Therefore, the kit was replaced with a new kit to complete the procedure.No injury to the patient occurred." additional information received states "there was a burr like deformation near the hub on the dilator".There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one dilator for analysis.Obvious signs of use were observed on the returned sample.Visual analysis revealed that the dilator body was deformed towards the proximal end.The extrusion outer diameter was clearly narrower at the proximal end compared to the distal end.The material of the dilator was also frayed with the appearance of a molding defect.Microscopic examination confirmed the damage.No other defects or anomalies were observed.The deformed area of the dilator extrusion measured approximately 0mm - 100mm from the proximal end of the dilator extrusion.The dilator body from the hub to the tip measured 3.97638", which is within the specification limits of 3 3/4" - 4 1/4" per the dilator graphic.The dilator outer diameter at the proximal (deformed) end measured 0.0970", which is not within the specification limits of 0.090" - 0.092" per the dilator extrusion graphic.The dilator outer diameter distal to the damaged portion (the undamaged area) measured 0.1120", which is also not within the specification limits of 0.090" - 0.092" per the dilator extrusion graphic.The dilator inner diameter at the tip measured 0.036", which is within the specification limits of 0.036" - 0.038" per the dilator graphic.A lab inventory guidewire with the same diameter as the guidewire packaged with this finished kit was passed through the dilator.The guidewire could not pass completely through, as it appeared to get stuck at the deformed area on the dilator.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit , states, "do not use if package is damaged." the report that a dilator was damaged/deformed was confirmed through complaint investigation.Visual analysis revealed that the dilator body contained deformations towards the proximal end with the appearance of a molding defect.The dilator did not meet all relevant dimensional requirements or functional requirements due to the deformity.Based on the customer report and the sample received, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 16 GA X 12" (30 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: 21847613
• Report Number: 9680794-2025-00307
• Device Sequence Number: 8101854
• Product Code: DQY
• UDI-Device Identifier: 10801902121148
• UDI-Public: (01)10801902121148(11)240716(17)280831(10)14F24G0114(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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
• Device Catalogue Number: CS-04400
• Device Lot Number: 14F24G0114
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown