MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14402
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "catheter kinked (obstructed), unable to pass guide wire".
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided one photo for analysis.The image showed a cvc and guidewire assembly within its package.The report of a kinked catheter could not be confirmed with the customer provided image.The customer also returned one two-lumen cvc and guidewire with arrow advancer for analysis.Signs of use were observed.Visual analysis revealed that the catheter body was kinked towards the proximal end.The appearance of the kinking appears consistent with undue force applied during insertion.No other defects/anomalies were observed with the catheter integrity.The kink in the catheter body was measured at 7/8" from the juncture hub.A slight bend was also noted at 3 1/2" from the juncture hub.The catheter body length measured 5 1/16", which is within the specification limits of 4 13/16" - 5 3/16" per the catheter product drawing.The catheter body outer diameter measured 0.0545", which is within the specification limits of 0.054" - 0.058" per the catheter extrusion product drawing.The catheter body inner diameter at the distal tip measured 0.021", which is within the specification limits of 0.021" - 0.023" per the catheter product drawing.A lab inventory guidewire with a diameter of 0.018" was inserted through the catheter.Little to no resistance was encountered as the guidewire passed completely through the assembly.Performed per ifu statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".A device history record review was performed and no relevant findings 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 customer report of a kinked catheter was confirmed through complaint investigation.Visual analysis revealed that the catheter body showed evidence of a kink.Despite the damage, the catheter met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings to suggest a manufacturing issue.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "catheter kinked (obstructed), unable to pass guide wire".

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20986691
• Report Number: 9680794-2024-01261
• Device Sequence Number: 8599497
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: (01)00801902102140(11)240429(17)290331(10)14F24D0133(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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 Catalogue Number: CS-14402
• Device Lot Number: 14F24D0133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• 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
• Patient Sex: Unknown