MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number	CS-15853
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: during the insertion of a central catheter in a patient, the doctor encountered an issue.The guide was blocked from insertion and kinked.Another device was used successfully.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one guide wire assembly and a lidstock for analysis.The dilator involved with this complaint was not returned.Signs of use in the form of biological material were observed.Visual analysis revealed that the guide wire was kinked in two locations adjacent to the distal j-bend.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were smooth and uniform.Visual analysis could not be performed on the dilator as it was not returned for analysis.The kinks on the guide wire measured 561mm and 575mm from the proximal end.The guide wire total length measured 602mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.791mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.Dimensional analysis could not be performed on the dilator as it was not returned for analysis.Functional analysis could not be performed as the dilator was not returned for analysis.A manual tug test confirmed that the distal and proximal welds were secure and intact.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".The report of a kinked guide wire was confirmed through complaint investigation; however, the dilator was not returned for analysis.Visual analysis revealed that the guide wire was kinked adjacent to the distal j-bend.The guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, the root cause cannot be confirmed without the dilator also returned for analysis.Therefore, the root cause for this complaint is undetermined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: during the insertion of a central catheter in a patient, the doctor encountered an issue.The guide was blocked from insertion and kinked.Another device was used successfully.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only**.
Event or Problem Description
It was reported that: during the insertion of a central catheter in a patient, the doctor encountered an issue.The guide was blocked from insertion and kinked.Another device was used successfully.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18309153
• Report Number: 3006425876-2023-01226
• Device Sequence Number: 6718459
• Product Code: DQY
• UDI-Device Identifier: 10801902029017
• UDI-Public: (01)10801902029017(11)220825(17)260930(10)71F22H2442(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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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: 09/30/2026
• Device Catalogue Number: CS-15853
• Device Lot Number: 71F22H2442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/04/2024; Not provided
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/05/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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; NOT REPORTED
• Patient Sex: Unknown