MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15232-VFE

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 09/13/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the spring wire guide was found kinked during use on the patient.No patient harm was reported.The patient's condition is reported as fine.

Event Description

It was reported the spring wire guide was found kinked during use on the patient.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned the catheter body, guide wire, and product lidstock for analysis.No obvious signs of use were observed on the returned components.Visual analysis revealed the guide wire is kinked in multiple locations along the body.The distal j-bend was slightly misshapen but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and appear full and spherical.The kink in the guide wire measured 56mm, 222mm, 240mm, 300mm, and 460mm from the proximal tip.The overall length of the guide wire measured 100cm which is within the specification limits of 98.75cm-101.25cm per the guide wire product drawing.The outer diameter of the guide wire measured 0.03770", which is within the specification limits of 0.0375 - 0.0385" per the guide wire product drawing.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit which states "advance guidewire through needle or micro-introducer sheath (where used) into vein." the guide wire was advanced through a lab inventory ars and lab inventory introducer needle.Major resistance was observed at the kinking; however, the undamaged portion of the guide wire was able to pass as expected.A manual tug test confirmed that both the distal and proximal welds were 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." the report that the guide wire kinked during use was confirmed through examination of the returned sample.Visual analysis revealed that the guide wire was kinked in multiple locations along the body.The returned guide wire met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 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: 15545373
• MDR Text Key: 306440574
• Report Number: 9680794-2022-00619
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141051
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 13F22B0115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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: N/A.; N/A.