MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18 GA X 8CM; CATHETER PERCUTANEOUS

Catalog Number SAC-00818-PBX

Device Problem Unraveled Material (1664)

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

Event Date 04/25/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

The complaint is reported as: "at the time of insertion, the guide was no longer rigid at its end.A new device had to be used, there was no consequence on the patient.".

Manufacturer Narrative

Qn# (b)(4).The customer returned one guide wire and catheter within an sac kit for analysis.Signs of use were observed.Visual analysis revealed that the guide wire was unraveled at the distal weld.One bend was also observed towards the distal end of the guide wire.Microscopic examination confirmed that the core wire was broken adjacent to the distal weld and the weld was present at the end of the coil wire.The distal and proximal welds were both present and spherical.The bend in the guide wire began 291 mm from the proximal end.The overall length of the guide wire measured 338mm which is within the specification limits of 331mm - 340mm per the guide wire product drawing.The outer diameter of the guide wire measured 0.620mm which is within the specification limits of 0.61mm - 0.64mm per the guide wire product drawing.Functional inspection could not be performed due to the damage to the guide wire.A manual tug test confirmed that the proximal weld was 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 informs the user , "precaution: use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire." the customer report of an unraveled guide wire was confirmed through investigation of the returned sample.Dimensional inspection requirements were met, and a device history record review did not reveal any evidence of a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0 or 2.75 pounds 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 likely contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: "at the time of insertion, the guide was no longer rigid at its end.A new device had to be used, there was no consequence on the patient.".

• Brand Name: ARROW ARTERIAL CATH SET: 18 GA X 8CM
• 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: 16961315
• MDR Text Key: 315553489
• Report Number: 3006425876-2023-00557
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K171146
• 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
• Report Date: 05/15/2023

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: SAC-00818-PBX
• Device Lot Number: 71F23B0384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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: NOT REPORTED.; NOT REPORTED.