MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18 GA X 8CM; CATHETER PERCUTANEOUS

Catalog Number SAC-00818-PBX

Device Problems Unable to Obtain Readings (1516); Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2023

Event Type  malfunction  

Event Description

It was reported that: less than 24 hours after a catheter was changed from left radial to right radial by two experienced clinicians, the catheter lost arterial pressure signal and it was impossible to sample blood.All the maintenance measures have been respected.The consequence was reported as a loss of continuous monitoring.No patient harm was reported.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: less than 24 hours after a catheter was changed from left radial to right radial by two experienced clinicians, the catheter lost arterial pressure signal and it was impossible to sample blood.All the maintenance measures have been respected.The consequence was reported as a loss of continuous monitoring.No patient harm was reported.

Manufacturer Narrative

Qn#(b)(4).The customer returned one arterial catheter for analysis.Signs of use in the form of biological material were present on the catheter body.Visual inspection of the catheter did not reveal any defects or anomalies.The total length of the catheter body measured 85 mm, which is within specifications of 82-86 mm per catheter product drawing.The outer diameter of the catheter body measured 1.272 mm, which is within specifications of 1.24-1.30 mm per catheter product drawing.The inner diameter of the catheter tip measured.7112 mm, which is within specifications of a minimum inner diameter of 0.69 mm per catheter product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit which states, "thread tip of catheter over guidewire." a lab inventory 0.025" swg was able to pass through the catheter with minimal resistance.Biological material was observed exiting when the distal end when the swg was passed through.The catheter was flushed with a water filled lab inventory syringe and no leaks or blocks were detected.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with this kit warns the user, "do not apply tape, staples, or sutures directly to the catheter body to reduce risk of damaging catheter, impeding catheter flow, or adversely affecting monitoring capabilities.Secure only at indicated stabilization locations." the customer complaint of a blocked catheter was not able to be confirmed by a complaint investigation of the returned sample.The r eturned catheter passed all relevant dimensional and functional testing.A device history record review was performed, and no relevant findings were identified.Based on the sample returned no problems were identified with the returned device.Teleflex will contin ue to monitor and trend on complaints of this nature.

• Brand Name: ARROW ARTERIAL CATH SET: 18 GA X 8CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16617576
• MDR Text Key: 312014029
• Report Number: 3006425876-2023-00280
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K171146
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAC-00818-PBX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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