MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2L 5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number CS-14502

Device Problem Unraveled Material (1664)

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

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the guidewire "shredded" inside a patient during catheter passage.It was reported no piece of the wire was left in the patient.A chest x-ray was performed.No injury or harm to the patient was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one swg for analysis.The customer also provided two photos for analysis.Visual analysis revealed that the core wire was separated into two parts.The distal j-bend did not appear misshapen.Microscopic examination revealed that the core wire point of separation ends was slightly tapered, indicating undue force contributed to the breakage.The distal and proximal welds appeared to be full and spherical.The separation points of the core wire measured 20mm from the distal tip and 433mm from the proximal tip.The total length of the returned core wire measured to be 453mm which is within the specification limits of 449.2mm-458.8mm per the swg graphic drawing.The guide wire outer diameter measured 0.518mm , which is within the specification limits of 0.508mm-0.533mm per the swg graphic drawing.Functional inspection could not be performed due to the severity of the damage observed.A manual tug test confirmed that both welds were secure and intact.A device history record review was performed, and no relevant findings were identified.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." the report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken 20 mm from the distal weld.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0 pounds force when tested in accordance with iso 11070 test configuration.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.

Event Description

It was reported the guidewire "shredded" inside a patient during catheter passage.It was reported no piece of the wire was left in the patient.A chest x-ray was performed.No injury or harm to the patient was reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 2L 5 FR X 13 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16565113
• MDR Text Key: 312010087
• Report Number: 9680794-2023-00173
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/17/2023

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 Catalogue Number: CS-14502
• Device Lot Number: 14F21A0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2021
• 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
• Treatment: NOT REPORTED; NOT REPORTED