MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET:20 GA CATH/22 GA NDL; WIRE GUIDE CATHETER

Catalog Number FA-04020

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

It was reported that: guidewire won't pass through the needle.Additional information: there was a delay in the procedure but there was no other reported patient harm or consequence from the incident.The wire was returned for investigation and the engineers noted that it was kinked.Associated to 9680794-2024-00104, 9680794-2024-00105, 9680794-2024-00106 and 9680794-2024-00107.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4) the customer report of guide wire/needle resistance was confirmed through complaint investigation of the returned sample.The customer returned one opened arterial catheterization kit for analysis.Signs-of-use were observed inside the returned device.Visual inspection of the guide wire revealed offset coils towards the distal end.Microscopic examination confirmed the damage.The distal weld was present and appeared full and spherical.The guide wire offset coils were located 1-3mm via calibrated ruler from the distal end.The guide wire length from the handle to the distal end measured 9 1/2" via calibrated ruler which was within the specifications of 9 1/4"-9 1/2" per product drawing.The guide wire outer diameter (od) measured 0.44mm via calibrated caliper which was within the specifications of 0.432-0.457mm per product drawing.Functional inspection was performed on the returned device based on the instructions-for-use (ifu) provided with the kit which states, "remove guard.Trial advance and retract guidewire through needle using guidewire handle to ensure proper function." a lab inventory guide wire was attempted to be threaded through the cannula.The guide wire was not able to pass.Due to the large amounts of biomaterial in the device, the material causing the blockage within the cannula could not be confirmed.The instructions-for-use (ifu) provided with the kit warns the user, "precaution: if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture." a device history record review was performed, and no relevant findings were identified.Based on the observed failure mode and the comments from manufacturing, the probable root cause is likely manufacturing related.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that: guidewire won't pass through the needle.Additional information: there was a delay in the procedure but there was no other reported patient harm or consequence from the incident.The wire was returned for investigation and the engineers noted that it was kinked.Associated to 9680794-2024-00118, 9680794-2024-00104, 9680794-2024-00105, 9680794-2024-00106 and 9680794-2024-00107.

• Brand Name: ARROW ARTERIAL CATH SET:20 GA CATH/22 GA NDL
• Type of Device: WIRE GUIDE CATHETER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18685275
• MDR Text Key: 335197000
• Report Number: 9680794-2024-00118
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K810675
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FA-04020
• Device Lot Number: 13F22F0071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Age: 95 YR
• Patient Sex: Male