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

Model Number IPN030909

Device Problems Unraveled Material (1664); Deformation Due to Compressive Stress (2889)

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

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the spring wire guide was found kinked during use on the patient.No patient harm was reported.The patient's condition is reported as fine.

Event Description

It was reported the spring wire guide was found kinked during use on the patient.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The report of an unraveled guide wire was confirmed through complaint investigation of the returned sample.The customer returned one opened cvc kit including one swg assembly evaluation.Definite signs of use in the form of biological material were observed on the returned guide wire.Visual analysis revealed that the guide wire contained multiple kinks.The coils at one kink appeared to be unraveled and broken.The distal j-bend was slightly misshapen but intact.Microscopic examination confirmed the damage and, despite the unraveling, revealed that the distal and proximal welds were secure and intact.The kinks measured 486mm and 584mm from the proximal tip of the guide wire.The guide wire length measured 600mm, which was within the specification limits of 596mm-604mm per the guide wire product drawing.All these measurements were done via calibrated ruler.The guide wire outer diameter (od) measured 0.796mm via calibrated micrometer, which was within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.Functional inspection was performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it pass es through syringe valves or into introducer needle." the guide wire was inserted through the returned arrow raulerson syringe (ars)/18ga introducer needle assembly, and the undamaged portions were able to pass with little to no difficulty.Resistance was met at the sites of kinking/unraveling.A manual tug test confirmed that the distal and proximal welds were intact.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage.Do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." a device history record review was performed, and no relevant findings were identified.Arrow guide wires of this size were designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification was higher than the bs en iso standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy might present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage might occur if a force greater than the design specification was applied during removal.Based on the customer report that the damage was observed during use 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.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17313439
• MDR Text Key: 319102083
• Report Number: 3006425876-2023-00678
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902105455
• UDI-Public: 00801902105455
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• 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: 06/20/2023

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 Model Number: IPN030909
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 71F22F3302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• 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