MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC RA CATH SET: 20 GA X 1-1/2"; WIRE GUIDE CATHETER

Catalog Number RA-04220

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

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "swg hard to advance.Used on a patient, but no patient harm." the returned device was noted to be kinked.

Event Description

It was reported that "swg hard to advance.Used on a patient, but no patient harm." the returned device was noted to be kinked.

Manufacturer Narrative

Qn # (b)(4).The customer returned one arterial catheterization device for evaluation.Signs of use were observed inside the device.The guide wire was returned partially advanced through the needle cannula.The guide wire was fully retracted out of the needle cannula.Visual inspection revealed several kinks and bends in the guide wire.Microscopic examination confirmed the damage.The distal weld was present and observed to be full and spherical.Significant amounts of dried biomaterial were observed on the guide wire and inside the needle cannula.A bend was observed in the needle the main kinks in the guide wire were located 1-14mm from the distal end.The guide wire length measured 4 1/4" which is within the specifications of 4 6/32"-4 12/32" per product drawing.The guide wire outer diameter measured 0.44mm which is within the specifications of 0.432-0.457mm per product drawing.After the blockage in the cannula was cleared, the cannula inner diameter at the tip measured 0.0230", which is within the specification limits of 0.0226"-0.0240" per the cannula 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." the returned guide wire could not be reinserted into the cannula due to the damage.A lab inventory guide wire was inserted through the needle cannula.Resistance was observed, and biomaterial was observed exiting the needle cannula during insertion.Once the biomaterial was cleared, no resistance was observed and the device functioned as expected.No resistance was observed between the guide wire handle and the device chamber.A device history record review was performed with no relevant findings.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.Visual inspection revealed several kinks and bends in the guide wire.Resistance between the guide wire and needle cannula was observed, and it was determined that an accumulation of dried biomaterial inside the cannula was the likely cause of the resistance.The guide wire and needle met all relevant dimensional requirements and a device history record review did not reveal any manufacturing issues.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: RA CATH SET: 20 GA X 1-1/2"
• 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: 18795519
• MDR Text Key: 336404916
• Report Number: 9680794-2024-00244
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: RA-04220
• Device Lot Number: 14F23D0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• 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