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

Catalog Number CA-25703-A

Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported right ij placement with easy access and smooth first attempt, placed guidewire.The user was then unable to advance the catheter over the guidewire.The guidewire was removed and bent approximately 90 degrees.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one guide wire for analysis.Signs of use in the form of biological material were observed.The catheter was not returned.Visual analysis revealed that the guide wire contained one major kink.The j-bend was slightly misshapen.Microscopic examination confirmed the damage and revealed that the distal and proximal welds are secure and intact.Visual inspection of the catheter could not be performed as the catheter was not returned.The kinks on the guide wire length measured from the proximal weld.The guide wire length measured 602 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.Dimensional inspection of the catheter could not be performed as the catheter was not returned.The guide wire was inserted through a lab inventory arrow raulerson syringe (ars)/introducer needle assembly.Significant resistance was encountered at the locations of the kinking.However, it was observed that the non-kinked areas 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." functional inspection of the catheter could not be performed as the catheter was not returned.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and on there was one finding.Without the catheter returned it cannot be determined if this finding is relevant to the customer reported issue.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "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 one kink on the guide wire.The returned guide wire met all relevant dimensional requirements.Functional analysis revealed that the kinks met resistance when passing through a lab inventory needle/ars assembly; however, the non-kinked sections appeared functional.A device history record review was performed with no relevant findings.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 Description

It was reported right ij placement with easy access and smooth first attempt, placed guidewire.The user was then unable to advance the catheter over the guidewire.The guidewire was removed and bent approximately 90 degrees.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: 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: 16408784
• MDR Text Key: 309876429
• Report Number: 3006425876-2023-00181
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CA-25703-A
• Device Lot Number: 13F22H0611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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