MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN919472
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during insertion, the surgeon had to use force to remove the swg from catheter.The swg tip was unraveled.It was decided to remove the catheter, and a part of the swg was found stuck on the distal end of the catheter.During the insertion procedure, the swg got damaged by the dilator and was deformed during dilatation of the vein which caused the swg to bend.There was no clinical consequences to the patient.".
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire and product lidstock for analysis.Definite signs of use were observed on the returned guide wire.Neither the catheter nor the dilator were returned for evaluation.Visual analysis revealed that the guide wire was unraveled from the distal weld.The coil wire was additionally separated in the middle of the body.Multiple kinks were observed along the guide wire body and a long continuous bend was present on the distal portion of the core wire.The distal j-bend was misshapen but intact.Microscopic examination confirmed that the coil wire was separated from the core wire at the distal weld and revealed that both welds were full and spherical.Visual analysis of the dilator and catheter could not be performed as they were not returned for analysis.The kinks in the guide wire measured 31mm and 341mm from the proximal tip.The overall length of the guide wire core wire measured 599mm which is not within the specification limits of 596-604mm per product drawing.The guide wire outer diameter measured 0.85mm which is within the specifications of 0.838-0.877mm per product drawing.Functional testing of the guide wire could not be accurately performed due to the damage.A manual tug test revealed that the proximal weld is secure and intact.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this 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 report of a separated guide wire was confirmed through examination of the returned sample.The guide wire core wire was broken 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 2.75 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 potential root cause could not be determined based upon the information provided and without the dilator or catheter from the reported event 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 insertion, the surgeon had to use force to remove the swg from catheter.The swg tip was unraveled.It was decided to remove the catheter, and a part of the swg was found stuck on the distal end of the catheter.During the insertion procedure, the swg got damaged by the dilator and was deformed during dilatation of the vein which caused the swg to bend.There was no clinical consequences to the patient.".

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19308439
• Report Number: 3006425876-2024-00471
• Device Sequence Number: 7333037
• Product Code: DQY
• UDI-Device Identifier: 00801902102119
• UDI-Public: 00801902102119
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: IPN919472
• Device Catalogue Number: CS-12123-F
• Device Lot Number: 71F23K1610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2023
• 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