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

Catalog Number	CV-47702-E
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the passage of the catheter, the tip expanded, making it impossible for it to progress." a different catheter was used.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one two-lumen catheter and a guidewire for analysis.Signs of use in the form of biomaterial were observed on the returned components.Visual inspection revealed that the catheter tip was slightly misshapen at the distal end.The extrusion proximal to the taper of the tip seemed to be wider than the rest of the extrusion.Biological material was observed within the proximal extension line.No other defects or anomalies were observed on the returned catheter.The overall length of the catheter body measured 218mm, which is within specification limits of 207mm - 227mm per the catheter product drawing.The outer diameter of the catheter body near the proximal end measured 2.38mm, which is within the specification limits of 2.36mm - 2.46mm per the catheter extrusion product drawing.However, the outer diameter near the distal end (marked in red below) measured 2.52mm, which is not within the specification limits of 2.36mm - 2.46mm per the catheter extrusion product drawing.The inner diameter of the catheter at the distal tip measured 0.9652mm, which is within the specification limits of 0.95mm - 1.02mm per the catheter product drawing.The catheter was functionally tested per the instructions for use (ifu).The ifu states, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed." the catheter was connected to a lab inventory syringe.Both distal and proximal extension lines flushed as intended.No leaks or blocks were observed.A lab inventory guidewire of the same size as provided in the kit was inserted through the returned catheter.No resistance was met and it freely passed through without issue.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "do not apply excessive force in placing or removing guidewire , dilator, or access device.Excessive force can cause component damage or breakage." the complaint of an expanded catheter tip was confirmed by complaint investigation of the returned sample.Visual examination revealed a slight expansion in the outer diameter of the catheter extrusion towards the distal end.Dimensional inspection revealed that the outer diameter at the distal end of the catheter was out of specification.Based on these circumstances, manufacturing was likely the root cause.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "during the passage of the catheter, the tip expanded, making it impossible for it to progress." a different catheter was used.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• 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: 21832583
• Report Number: 3006425876-2025-00379
• Device Sequence Number: 4175264
• Product Code: FOZ
• UDI-Device Identifier: 10801902102536
• UDI-Public: (01)10801902102536(11)240515(17)260306(10)71F24E0017(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K993691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• 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 Expiration Date: 03/06/2026
• Device Catalogue Number: CV-47702-E
• Device Lot Number: 71F24E0017
• 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: 05/09/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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