MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CV-25703-E
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "specialist refers to performing the guide step which did not pass completely; therefore he decides to remove, at the moment of removing it is evident that the guide is suffering deformation." additional information reports "the guide suffers a stretching makin manipulation impossible".No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Udi#:(b)(4).The customer returned one guide wire and the product lidstock for evaluation.Signs-of-use were observed on the returned guide wire.The catheter was not returned.Visual examination revealed the guide wire was unraveled from the proximal weld and was kinked/distorted in several locations along the body.The broken proximal core wire was protruding out of the coil wire.The distal j-bend was misshapen but intact.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld.The exposed distal core wire tip is tapered and discolored at the point of separation.Both welds were present and appeared full and spherical.Visual inspection of the catheter could not be performed as it was not returned for evaluation.The major kink in the guide wire body was measured at 60mm and 465mm from the distal tip.The broken core wire measured 600mm in length, which is within the specification of 596-604 mm per guide wire product drawing therefore no pieces of the core wire appear to be missing.The outer diameter (od) of the guide wire measured 0.793 mm which is within the od specification of 0.788-0.826 mm per guide wire product drawing.Dimensional inspection of the catheter could not be performed as it was not returned for evaluation.Functional inspection of the guide wire could not be performed due to the condition of the returned sample.Functional inspection of the catheter could not be performed as it was not returned for evaluation.A manual tug test confirmed that the distal weld was intact.A device history record review was performed with no relevant findings.The report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the proximal 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.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 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 "specialist refers to performing the guide step which did not pass completely; therefore he decides to remove, at the moment of removing it is evident that the guide is suffering deformation." additional information reports "the guide suffers a stretching makin manipulation impossible".No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19352996
• Report Number: 3006425876-2024-00491
• Device Sequence Number: 17950098
• Product Code: FOZ
• UDI-Device Identifier: 10801902029390
• UDI-Public: 10801902029390
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 04/25/2024

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
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: CV-25703-E
• Device Lot Number: 71F23C1756
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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