MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 5.5 FR X 8 CM; CATHETER PERCUTENEOUS

Model Number	IPN036264
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during the insertion, the guide became stuck in the central line, making it impossible to remove it, even with force.In the end, the doctors removed the central line with the guide and observed that the guide was completely unravelled.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned two, defective guide wires for analysis.One guide wire was unraveled, and one was kinked.Signs of use in the form of biological material were observed on both samples.The catheter involved with this complaint was not returned.The customer was contacted to determine why a second guide wire was returned.They confirmed that one of the guide wires was used without an issue.From this, it was determined that the kinked guide wire was returned for reference only; however, the circumstances on why it is kinked cannot be determined.Visual examination revealed the guide wire was unraveled towards the distal end.The distal end of the core wire was broken and protruding out of the coil wire.The j-bend was slightly misshapen but intact.Microscopic examination of the guide wire confirmed the core wire was broken near the distal weld.Both welds appeared full and spherical.During the handling of the guide wire as part of the visual analysis, the unraveled section of the coil wire became separated.Visual inspection of the catheter could not be performed as the catheter was not returned.For the unraveled guide wire, the length from the proximal weld to the point of separation on the core wire measured 17 15/16, which is within the specification limits of 17 11/16"-18 1/16" per the guide wire product drawing.The outside diameter of the guide wire measured 0.017", which is within specifications of 0.017"-0.018" per guide wire product drawing.Dimensional inspection of the catheter could not be performed as the catheter was not returned.Functional analysis could not be performed due to the severity of the damage on the guide wire.Also, the catheter involved with this complaint was not returned.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed on the guide wire and catheter and no relevant manufacturing issues were identified.The ifu provided with the kit informs the user, "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 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 report of an unraveled guide wire was confirmed through examination of the returned sample.The guide wire core wire was broken directly adjacent to the distal weld.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0 pounds force.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 contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "during the insertion, the guide became stuck in the central line, making it impossible to remove it, even with force.In the end, the doctors removed the central line with the guide and observed that the guide was completely unravelled.".

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 FR X 8 CM
• Common Device Name: CATHETER PERCUTENEOUS
• 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: 18967146
• Report Number: 3006425876-2024-00255
• Device Sequence Number: 15027575
• Product Code: DQY
• UDI-Device Identifier: 10801902122619
• UDI-Public: 10801902122619
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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 Model Number: IPN036264
• Device Catalogue Number: CV-15553
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 03/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female