MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROWCVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number IPN919475

Device Problem Unraveled Material (1664)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

Customer complaint reports: when inserting a catheter after inserting the introducer needle and the guidewire, nurses wanted to remove the introducer needle but the guidewire unravelled at the time of removal.The nurses therefore had to remove it entirely by pulling on it.It was reported the incident led to a postponement of dialysis and the patient also bled heavily.Additional information received from customer on (b)(6) 2022 reports patient was thrombocytopenic and therefore at greater risk of bleeding.Patient condition is "fine".No medical intervention was required.

Event Description

Customer complaint reports: when inserting a catheter after inserting the introducer needle and the guidewire, nurses wanted to remove the introducer needle but the guidewire unravelled at the time of removal.The nurses therefore had to remove it entirely by pulling on it.It was reported the incident led to a postponement of dialysis and the patient also bled heavily.Additional information received from customer on 30dec2022 reports patient was thrombocytopenic and therefore at greater risk of bleeding.Patient condition is "fine".No medical intervention was required.

Manufacturer Narrative

(b)(4).The customer provided one photo of the defect.The photo shows an unraveled guide wire.The customer returned a single guide wire for analysis.No obvious signs of use were observed on the returned guide wire.Visual analysis of the guide wire revealed that it was unraveled from the distal end and was kinked/bent in multiple locations along the body.The core wire distal j-bend was exposed out of the coil wire.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.Both welds were present and appeared full and spherical.Visual inspection of the needle could not be performed as the needle was not returned.The major kinks/bends in the guide wire body measured 392mm and 425mm from proximal weld.The broken core wire measured 682mm, which is within the specification limits of 678mm - 688mm per guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The outer diameter of the guide wire measured 0.858mm, which is within the specification limits of 0.838mm - 0.877mm per guide wire product drawing.Dimensional analysis of the needle could not be performed as the needle was not returned for analysis.Functional testing of the returned guide wire could not be performed due to the damage to the returned guide wire.Functional analysis of the needle could not be performed as the needle was not returned for analysis.A manual tug test revealed that the proximal weld is intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this 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 report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken towards the distal weld.The guide wire passed all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard 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 these circumstances, unintentional use error likely contributed to this event, however, the probable cause of guide wire and needle resistance could not be determined based upon the information provided and without the needle being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROWCVC SET: 3-LUMEN 12 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16226743
• MDR Text Key: 308459950
• Report Number: 3006425876-2023-00132
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

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 Model Number: IPN919475
• Device Catalogue Number: CS-15123-F
• Device Lot Number: 71F22E0132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• 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