MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 16CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CV-22703-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the physician, while preparing the cvc set before injecting it into the patient, discovered that the wire in the package was kinked." associated compalints: 3006425876-2024-00935, 3006425876-2024-00934, and 3006425876-2024-00933.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer provided two photos for analysis.The photo shows the guide wire was assembled inside the guide wire tubing and was kinked.The tubing was observed to be inserted into the blue advancer.The tubing straightener nor the cap were present.The customer also returned one, opened cvc kit for analysis.The guide wire cap and straightening tube were not returned.It was noted that the guide wire tubing was not inserted into the blue advancer.This does not match how the sample is pictured in the customer image.Therefore, it is assumed that the tubing disconnected while in transit to the morrisville site.No obvious signs of use were observed on the sample.The guide wire was observed to have two kinks towards the distal j-bend.The distal j-bend was misshapen but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.During full assembly, the kinking on the guide wire would have been located within the guide wire straightening tube during packaging , shipping, and storage, protecting it from damage.No other defects or anomalies were observed on the returned guide wire assembly.The kinks in the guide wire were located 400mm and 415mm from the proximal weld.The total guide wire length measured 456mm, which is within the specification limits of 450mm-458mm per the guide wire product drawing.The guide wire outer diameter measured 0.790mm, which is within the specification limits of 0.0788mm-0.826mm per the guide wire product drawing.The guide wire was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe (ars) approximately 10 cm until it passes through syringe valves or into introducer needle".The guide wire was advanced through a lab inventory ars/18ga introducer needle subassembly to functionally test the guide wire.The undamaged portions of the guide wire passed through both components with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Two kinks were observed towards the distal end of the guide wire body.The guide wire met all relevant dimensional, and a device history record review was performed with no relevant findings.During normal assembly, the kinked portion of the guidewire would be protected within the guide wire cap/straightening tube of the advancer assembly; however, both components were missing from the returned assembly.Based on the customer report and sample received, the potential root cannot be determined as it is unknown when the damage occurred.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that "the physician, while preparing the cvc set before injecting it into the patient, discovered that the wire in the package was kinked." associated complaints: 3006425876-2024-00935, 3006425876-2024-00934, 3006425876-2024-00933 and 3006425876-2024-00930.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 16CM
• 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: 20332960
• Report Number: 3006425876-2024-00930
• Device Sequence Number: 21264479
• Product Code: FOZ
• UDI-Device Identifier: 10801902029338
• UDI-Public: (01)10801902029338(11)230920(17)250823(10)71F23J0779(21)
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 08/23/2025
• Device Catalogue Number: CV-22703-E
• Device Lot Number: 71F23J0779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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