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

Catalog Number	CS-22123-F
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "in the emergency, the doctor found the swg kinked during used on the same patient." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include 3006425876-2024-00381.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one guide wire for evaluation.Visual examination revealed the guide wire was unraveled from the proximal weld and was kinked in multiple locations along the body.The distal j-bend was slightly misshapen but intact.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld.Both welds were present and appeared full and spherical.The major kinks in the guide wire body measured 211mm, 295mm, and from the proximal tip.The broken core wire measured 679mm in length, which is not within the specification of 596-604mm per guide wire product drawing.The outside diameter of the guide wire measured 0.849mm which is within the outer diameter specification of 0.838-0.877mm per guide wire product drawing.Due to the dimensional discrepancy between the returned guide wire length and reported material code specification limits, the customer either reported the incorrect material number or returned the incorrect guide wire.Functional inspection could not be performed due to the damage to the guide wire.A manual tug test confirmed that the distal weld was intact.A device history record review was performed, and no relevant findings were identified.The instructions-for-use provided with this kit warns 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 report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.No manufacturing defects were found during this investigation.Arrow guide wires of this outer diameter 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, the appearance of the damage is consistent with unintentional use error caused or contributed to this event.However, due to the dimensional discrepancy between the returned sample and the reported finished good, the potential root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "in the emergency, the doctor found the swg kinked during used on the same patient." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include 3006425876-2024-00381.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 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: 19220296
• Report Number: 3006425876-2024-00383
• Device Sequence Number: 20589495
• Product Code: FOZ
• UDI-Device Identifier: 00801902102188
• UDI-Public: 00801902102188
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• 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
• Report Date (Section B): 03/26/2024

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 Expiration Date: 12/20/2024
• Device Catalogue Number: CS-22123-F
• Device Lot Number: 71F23B1359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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.
• Patient Sex: Unknown