MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN916435
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " identification of the vein, insertion of the swg and dilator - without problems.The central catheter was inserted over the swg.Upon removing the swg from the central catheter, damage was observed (splitting in the distal third of the swg)." there was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Udi# (b)(4).The customer returned one guide wire and the product lidstock for evaluation.The catheter was not returned.The guide wire was unraveled and showed evidence of use.Visual examination revealed the guide wire was unraveled from the distal weld and contained multiple kinks and bends in the guide wire body.The distal j-bend was protruding out of the coil wire.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld and that the weld was present at the end of the coil wire.The exposed distal core wire tip was pinched and discolored at the point of separation.Both welds appeared full and spherical.Visual inspection of the catheter could not be performed as the catheter was not returned.The major kink in the guide wire body were measured at 88mm from the distal tip.The broken core wire measured 603 mm 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 outside diameter (od) of the guide wire measured 0.80mm 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 the catheter was not returned.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage to the returned guide wire.Functional inspection of the catheter could not be performed as the catheter was not returned.A manual tug test confirmed that 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 this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in springwire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to re-move the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.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 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.This internal specification is higher than the 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 that " identification of the vein, insertion of the swg and dilator - without problems.The central catheter was inserted over the swg.Upon removing the swg from the central catheter, damage was observed (splitting in the distal third of the swg)." there was no reported patient harm or consequence.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• 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: 19678031
• Report Number: 3006425876-2024-00647
• Device Sequence Number: 17851546
• Product Code: FOZ
• UDI-Device Identifier: 10801902029345
• UDI-Public: 10801902029345
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K900263
• 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): 06/06/2024

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: 12/14/2025
• Device Model Number: IPN916435
• Device Catalogue Number: CV-22854
• Device Lot Number: 71F24A1168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 91 KG