MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-15123-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor complained that the wires kinked easily then he cannot use properly." the device was removed and another cvc was inserted.No medical intervention required.The patient's current ocnditons is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The photo showed two guide wires.Clear evidence of kinking is visible on both guide wires.A complete visual inspection 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".The ifu also states, "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 customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photo.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.
Event or Problem Description
It was reported that "the doctor complained that the wires kinked easily then he cannot use properly." the device was removed and another cvc was inserted.No medical intervention required.The patient's current conditions is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire and the product lidstock for analysis.Signs of use were observed on the guide wire.The guide wire was observed to have multiple kinks throughout the body.The distal j-bend was slightly 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.The major kinks in the guide wire were located 26 mm, 43 mm, 58 mm, 280 mm, 469 mm, and 580 mm from the proximal tip.The overall length of the guide wire measured 680 mm which is within the specification limits of 678-688 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.844 mm which is within the specification limits of 0.838-0.877 mm per 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 approximately 10 cm until it passes through syringe valves or into introducer needle.".The guide wire was advanced through a lab inventory ars and 18ga introducer needle.Resistance was met at the sites of kinking.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 that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire had multiple kinks throughout the body.Despite this, the returned guide wire met all relevant dimensional/functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional user error 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 doctor complained that the wires kinked easily then he cannot use properly." the device was removed and another cvc was inserted.No medical intervention required.The patient's current conditions is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 12 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: 18977805
• Report Number: 3006425876-2024-00278
• Device Sequence Number: 20499627
• Product Code: FOZ
• UDI-Device Identifier: 00801902102164
• UDI-Public: 00801902102164
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K970864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/29/2024

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 Catalogue Number: CS-15123-F
• Device Lot Number: 71F23B0839
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 04/12/2024; 05/08/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/30/2024; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 75 KG