MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 22 GA X 1-3/8; WIRE GUIDE CATHETER

Catalog Number RA-04122

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

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that" (b)(6) 2024, the doctor found the handle/chamber resistance during use on the patient.The patient was reported as fine post the procedure.

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

Qn#(b)(4).The customer returned one arterial catheterization kit for evaluation.No obvious signs of use were observed on the returned device.Visual inspection revealed offset coils near the guide wire distal end.Microscopic examination confirmed the damage.The distal weld was present and appeared full and spherical.After performing functional inspection , the proximal and distal openings of the needle cannulas were further examined.Traces of a white foreign substance were observed inside the needle hub.The offset coils in the guide wire measured 2mm from the distal end.The returned guide wire length measured 4 9/16", which is within the specifications of 4 7/16-4 11/16" per product drawing.The guide wire outer diameter measured 0.40mm, which is within the specifications of 0.381mm-0.404mm per product drawing.The needle cannula inner diameter measured 0.017", which is within the specifications of 0.0165"-0.018" per product drawing.Functional inspection of the returned device was performed per the instructions-for-use (ifu) provided with the kit which states, "stabilize position of introducer needle and carefully advance guidewire into vessel using guidewire handle.When the reference mark on the clear feed tube coincides with the edge of the internal cylinder of the guidewire handle the tip of the guidewire is located at the needle tip".Resistance was encountered while threading the returned guide wire through the needle cannula.The guide wire was able to pass through the proximal opening; however, it was not able to deploy completely through the cannula.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user , "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel.Precaution: if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture." the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Resistance was encountered while advancing the guide wire through the needle cannula during functional inspection for the returned device, which likely resulted in the damage observed.A capa was previously implemented to address this issue.The capa investigation indicates that the issue is manufacturing related.The relevant lots within the reported kit were manufactured (august 2022), which is prior to the implementation of the corrective action (b)(6) 2022).Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that"(b)(6) 2024, the doctor found the handle/chamber resistance during use on the patient.The patient was reported as fine post the procedure.

• Brand Name: ARROW RA CATH SET: 22 GA X 1-3/8
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18658124
• MDR Text Key: 334734041
• Report Number: 9680794-2024-00126
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K810675
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RA-04122
• Device Lot Number: 14F22H0163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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