MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-27702-E

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

It was reported the arrow raulerson syringe (ars) was found blocked and the spring wire guide couldn't be inserted in it during use on the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned a cvc catheter and a spring-wire guide (swg) inserted through an introducer needle/arrow raulerson syringe (ars) subassembly for analysis.Signs of use in the form of biological material were observed on the swg.Visual analysis revealed that the swg was inserted through the ars/introducer needle subassembly and was separated around the middle of the extrusion.The separated portion (proximal half) was not returned for analysis.Two major kink/bends were also observed near the point of separation.Microscopic examination confirmed the separation.It was also noted that the distal j-bend was misshapen and contained offset coils.No other defects or anomalies were observed.Visual inspection could not be performed on the separated portion of the swg as it was not returned for analysis.The two major kinks in the guide wire measured 190mm and 224mm from the distal weld.The core wire length measured 252mm, which indicates that 344mm-352mm of the guide wire was separated and was not returned for analysis (per guide wire product drawing).The guide wire outer diameter measured.801mm, which is within the specification limits of.788mm-.826mm per the marked guide wire graphic.The introducer needle outer diameter measured.04995", which is within the specification limits of.04950"-.05050" per the cannula product drawing.The cannula inner diameter at the distal and proximal ends measured.042", which is within the specification limits of.041"-.043" per the cannula product drawing.The defective guidewire was passed through the returned ars/introducer needle subassembly.Minor resistance was encountered due to the damage; however, the guide wire was able to pass completely through the subassembly.A lab inventory guide wire with a diameter of.032" was inserted through the returned ars/introducer needle subassembly.Little to no resistance was encountered as the guide wire passed completely through the subassembly.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed that the distal weld was secure and intact to the guide wire assembly.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The ifu provided with the kit informs the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The ifu also states, "do not apply undue force on guidewire to reduce risk of possible breakage".The report of a separated guide wire was confirmed through complaint investigation.Visual analysis revealed that the defective guide wire was returned inserted through the ars/introducer needle subassembly and was separated around the middle of the extrusion.Because the proximal half of the separation was not returned for analysis, a full visual and dimensional analyses could not be performed to confirm any additional damage/defects; however, functional testing with a lab inventory guide wire confirmed that the ars and introducer needle were functional.A device history record review was performed with no relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.The internal specification is higher than the bs en iso 11070:2014 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 the customer report and the sample received, the root cause cannot be determined without the separated portion of the guide wire also returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported the arrow raulerson syringe (ars) was found blocked and the spring wire guide couldn't be inserted in it during use on the patient.

• Brand Name: ARROW CVC SET: 2-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: 15222788
• MDR Text Key: 305105268
• Report Number: 3006425876-2022-00767
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

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: 05/12/2023
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F21E2047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 08/14/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• 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