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

Model Number IPN918498

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2023

Event Type  malfunction  

Event Description

It was reported that "during dilation the swg (spring wire guide) kinked.Due to this it would not be possible to advance a catheter over the wire.This occurred several times in (b)(6) 2023.How often this occurred and when cannot be provided, also the exact dates of the cases are not known." it was reported the patients were not injured and in each case a new spring wire guide was used.

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

(b)(4).The customer returned one guide wire and advancer for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the guide wire contained four kinks.One of the kinks was at the j-bend making it misshapen.Microscopic examination confirmed the damage and revealed that the distal and proximal welds are secure and intact.The kinks on the guide wire length measured 39mm, 317mm, 501mm, and 587mm from the proximal weld.The guide wire length measured 601 mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.790 mm , which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The guide wire was inserted through a lab inventory arrow raulerson syringe (ars)/introducer needle assembly.The undamaged portions of the guide wire were able to pass with little to no difficulty.Performed per ifu statement, "raise thumb and pull arrow advancer approximately 4 - 8 cm away from arrow raulerson syringe or introducer needle.Lower thumb onto arrow advancer and while maintaining a firm grip on guidewire, push assembly into syringe barrel to further advance guidewire.Continue until guidewire reaches desired depth." a manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) 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 of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed four kinks on the guide wire.The guide wire met all relevant dimensional and functional requirements.A device history record review was performed with no relevant findings.Based on the customer report that the damage was observed during use and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "during dilation the swg (spring wire guide) kinked.Due to this it would not be possible to advance a catheter over the wire.This occurred several times in january 2023.How often this occurred and when cannot be provided, also the exact dates of the cases are not known." it was reported the patients were not injured and in each case a new spring wire guide was used.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Type of Device: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16387414
• MDR Text Key: 309770614
• Report Number: 3006425876-2023-00140
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

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: 12/22/2023
• Device Model Number: IPN918498
• Device Catalogue Number: CV-25703
• Device Lot Number: 71F22A0862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED