MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CV-25703-E
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a major surgery, a patient in a state of deep anesthesia required a central venous catheter.Multiple attempts were made by both the anesthesiologist and the surgical oncologist; however, the guidewire did not pass easily, and the dilator failed to dilate as expected.The patient had no harm or injury.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a major surgery, a patient in a state of deep anesthesia required a central venous catheter.Multiple attempts were made by both the anesthesiologist and the surgical oncologist; however, the guidewire did not pass easily, and the dilator failed to dilate as expected.The patient had no harm or injury.
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The photo shows a guide wire.Visual analysis revealed that the guide wire was kinked; however, a complete visual inspection to evaluate the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".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: 3-LUMEN 7FR X 20CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 21630823
• Report Number: 3006425876-2025-00303
• Device Sequence Number: 8266324
• Product Code: FOZ
• UDI-Device Identifier: 10801902029390
• UDI-Public: (01)10801902029390(11)230901(17)250810(10)71F23H1739(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K900263
• 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): 02/27/2025

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: 08/10/2025
• Device Catalogue Number: CV-25703-E
• Device Lot Number: 71F23H1739
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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