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

Model Number IPN918765

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

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

Event Date 07/06/2023

Event Type  malfunction  

Event Description

It was reported "when inserting the catheter in the left internal jugular, the doctor observed that the guide was bent and unraveled, making removal from the vessel difficult." the user reported "the guide unraveled at the beginning from its insertion during its rise in the needle.I had to reverse the guide using the more rigid side which itself unraveled when i removed the guide from the central catheter." the guidewire was fully removed from the patient "but with difficulty"."as soon as the guidewire could be removed, the catheter was positioned with radiographic control, so the catheter was left in place." it was reported "there was no sequel" for the patient.Additional information received (b)(6) 2023 reported "the patient deceased, but the incident and the insertion of the device is not contributory to death.".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "when inserting the catheter in the left internal jugular, the doctor observed that the guide was bent and unraveled, making removal from the vessel difficult." the user reported "the guide unraveled at the beginning from its insertion during its rise in the needle.I had to reverse the guide using the more rigid side which itself unraveled when i removed the guide from the central catheter." the guidewire was fully removed fromt he patient "but with difficulty"."as soon as the guidewire could be removed, the catheter was positioned with radiographic control, so the catheter was left in place." it was reported "there was no sequel" for the patient.Additional information received 21july2023 reported "the patient deceased, but the incident and the insertion of the device is not c ontributory to death.".

Event Description

It was reported "when inserting the catheter in the left internal jugular, the doctor observed that the guide was bent and unraveled, making removal from the vessel difficult." the user reported "the guide unraveled at the beginning from its insertion during its rise in the needle.I had to reverse the guide using the more rigid side which itself unraveled when i removed the guide from the central catheter." the guidewire was fully removed from the patient "but with difficulty"."as soon as the guidewire could be removed, the catheter was positioned with radiographic control, so the catheter was left in place." it was reported "there was no sequel" for the patient.Additional information received 21july2023 reported "the patient deceased, but the incident and the insertion of the device is not contributory to death.".

Manufacturer Narrative

(b)(4).The customer returned one guide wire for analysis.Signs of use in the form of biological material was observed.No other components from the kit were returned.Visual analysis revealed that the guide wire was unraveled towards the distal end.Microscopic examination confirmed the damage and revealed that the core wire had separated directly adjacent to the distal weld.Both welds were full and spherical.The distal j-bend was observed to be misshapen with offset coils.The guide wire length from the proximal weld to the distal end of the core wire measured 601mm, which is within the specification of 596mm-604mm per guide wire product drawing; therefore, no piece of the core wire appears to be missing.The offset coils near the j-bend measured at 20mm from the distal tip.The outside diameter of the guide wire measured 0.810mm which is within the outer diameter specification of 0.788-0.826mm per product drawing.The undamaged end (proximal end) of returned guide wire was inserted through a lab inventory arrow raulerson syringe (ars) and introducer needle subassembly.Little to no resistance was observed as the guide wire passed 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 proximal weld was intact.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing issue.The ifu provided with the 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 unraveled was confirmed through examination of the returned sample.Visual analysis revealed that the core wire was broken adjacent to the distal weld.The guide wire met all functional/dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds of force.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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17493917
• MDR Text Key: 320730113
• Report Number: 3006425876-2023-00730
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902105339
• UDI-Public: 10801902105339
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2023

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 Operator: Health Professional
• Device Model Number: IPN918765
• Device Catalogue Number: CV-15703
• Device Lot Number: 71F23B1432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 08/31/2023; 10/04/2023
• Supplement Dates FDA Received: 09/05/2023; 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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: SEDATION AND INTUBATION; SEDATION AND INTUBATION; SEDATION AND INTUBATION