MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15312-VFE

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported "the guide got blocked in the needle, it was then impossible to move the guide and even to remove it." the needle and guidewire were removed together and another catheter kit used.No patient harm or injury reported.

Manufacturer Narrative

(b)(4).The customer returned one, guide wire inserted through an 18ga introducer needle.Signs of use in the form of biological material were observed on the guide wire.Visual analysis revealed that the guide wire was lodged inside the introducer needle.The guide wire was severely unraveled from the distal end.Several kinks/bends were also observed.Microscopic examination confirmed the damage and revealed that the core wire separated directly adjacent to the distal weld.The guide wire length from the proximal weld to the distal point of separation on the core wire measured approximately 100.5cm, (b)(4).The guide wire outer diameter measured.0375", (b)(4).The needle cannula outer diameter measured.0500", (b)(4).The cannula inner diameter (at proximal and distal end) measured.041", (b)(4).Significant resistance was required to free the guide wire from the needle cannula.Once freed, dried biological material was observed inside the coils of the guide wire.Once freed, the proximal end of the guide wire (undamaged portion) was inserted through the needle cannula.Little to no resistance was encountered as the guide wire passed with ease.Performed per ifu statement, "using the arrow advancer, advance guidewire through needle into vein".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 ifu provided with the kit informs the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The ifu provided, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of an unraveled guide wire due to needle resistance was confirmed through complaint investigation.Visual analysis revealed that the guide wire was lodged inside the needle and was unraveled towards the distal end.The guide wire was dislodged from the cannula.Microscopic examination confirmed the damage and revealed that the core wire was separated adjacent to the distal weld.The guide wire and cannula met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.The (b)(4).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 iso standard is applied during removal.Based on the customer report 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.

Event Description

It was reported "the guide got blocked in the needle, it was then impossible to move the guide and even to remove it".The needle and guidewire were removed together and another catheter kit used.No patient harm or injury reported.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• 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: 16214078
• MDR Text Key: 308561321
• Report Number: 9680794-2023-00059
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141051
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: CS-15312-VFE
• Device Lot Number: 13F20M0414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2020
• 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