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
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).
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 conditons is reported as "fine".
Additional Manufacturer Narrative
Qn# (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.
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.Both welds were present and were observed to be full and spherical.A manual tug test revealed the core wire was broken towards the distal tip, but the core wire was not exposed.Microscopic analysis revealed the distal core wire tip was tapered and discolored at the point of separation.Microscopic examination confirmed the damage to the guide wire body.The major kinks in the guide wire were located 18 mm, 372 mm and 398 mm from the proximal tip.The broken core wire measured 681 mm which is within the specification limits of 678-688 mm per guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The outer diameter of the guide wire measured 0.850 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 proximal end of the guide wire was advanced through a lab inventory ars and 18ga introducer needle.Resistance was met due to the kinking at the proximal end.The undamaged portions of the guide wire were able to pass through both components with little to no resistance.The distal end of the guide wire could not be functionally tested due to the nature of the damage.A manual tug test revealed that the core wire was broken towards the distal end.The proximal weld was 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 unraveled during use was confirmed through examination of the returned sample.The guide wire had multiple kinks throughout the body and the core wire was broken adjacent to the distal weld.Despite this, the returned guide wire met all relevant dimensional requirements, and a device history record review did not identify any manufacturing related issues.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error 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 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: 18977763
• Report Number: 3006425876-2024-00277
• Device Sequence Number: 6638991
• 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; 05/17/2024
• 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