MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-16553-E
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " the guidewire was found kinked after opening the package." prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The report that the guide wire kinked was confirmed through examination of the returned sample.The customer provided three photos for analysis; the photos show the guide wire with a kink towards the distal j-bend.The customer returned one swg within its advancer and product lidstock for analysis.The product tray was not returned.No signs of use were observed on the returned sample.Visual analysis confirmed that there was one kink due to offset coils towards the distal j-bend of the guide wire.The distal j-bend was not misshapen and was intact.Microscopic examination confirmed the defect.Both welds were present and were observed to be full and spherical.The kink in the guide wire was located 10mm via calibrated ruler from the distal tip.The overall length of the guide wire measured 454mm via calibrated ruler which was within the specification of 449.2-458.8 mm per guide wire product drawing.The outer diameter (od) of the guide wire measured 0.436mm via calibrated micrometer which was within the specification of 0.432-0.457 mm per guide wire product drawing.Functional inspection was performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through a lab inventory ars/21ga introducer needle assembly to functionally test the guide wire.Resistance was met at the site of kinking, however; the undamaged portions of the guide wire passed through both components with minimal resistance.The instructions-for-use (ifu) provided with the kit warns the user, "do not use if package is damaged".Based on the condition of the guide wire, comments from the manufacturing unit and the customer report, storage and shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " the guidewire was found kinked after opening the package." prior to use.There was no patient involvement.
Event or Problem Description
It was reported that " the guidewire was found kinked after opening the package." prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi #.Udi related data quality updates only.

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 18215261
• Report Number: 3006425876-2023-01142
• Device Sequence Number: 6721220
• Product Code: DQY
• UDI-Device Identifier: 30801931122981
• UDI-Public: (01)30801931122981(11)210507(17)250430(10)71F21E0347(21)
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 11/01/2023

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: 04/30/2025
• Device Catalogue Number: CS-16553-E
• Device Lot Number: 71F21E0347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/18/2023; Not provided
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 12/19/2023; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2021
• 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