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

Catalog Number SAC-00818-PBX

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Obstruction of Flow (2423)

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

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: "incident occurred on (b)(6) 2023.Within 48 hours after insertion, the catheter no longer worked properly: it was impossible to sample blood (no return of arterial blood) and the arterial pressure waveform gets flat resulting in a lack of blood pressure monitoring.Consequence: blood pressure monitored with the armband, allowing secure monitoring, but not sufficient for an intensive care department monitoring (drug therapy).We attempted to replace the catheter but with similar difficulties." it was reported the patient's condition is "stable".There was no patient injury or medical intervention needed.

Manufacturer Narrative

(b)(4).The customer returned one arterial catheter for analysis.Signs of use in the form of biological material were observed inside the extension lines.Visual analysis revealed that the catheter body contained two kinks.Microscopic examination confirmed the damage.No other defects or anomalies were observed.The kinks on the catheter measured 0mm and 23mm from the juncture hub.The catheter length from the juncture hub to the distal tip measured 84mm, which is within the specification limits of 83mm-86mm per the catheter product drawing.The catheter body outer diameter measured 1.24mm, which is within the specification limits of 1.24mm-1.30mm per the catheter extrusion product drawing.A lab inventory syringe filled with water was attached to the returned catheter and flushed.Biological material was observed exiting the distal tip of the catheter body.This biomaterial likely contributed to the customer report of a blocked catheter.After the biomaterial was removed, water was observed exiting the distal tip of the catheter with little to no difficulty.Performed per ifu statement, "maintain catheter patency according to institutional policies, procedures and practice guidelines".A lab inventory guide wire with a diameter of 0.025" was inserted through the distal tip of the catheter.Minor resistance was encountered at the location of the kinks; however, the guide wire was able to pass completely through the catheter.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire".The ifu also states, "use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire".The report of a blocked catheter was confirmed through complaint investigation of the returned sample.Visual analysis revealed two kinks on the catheter body.Additionally, congealed biological material was observed exiting the catheter body during functional testing.The kinking and the biomaterial both can contribute to any blockages encountered during the procedure.Despite this, the catheter met all relevant dimensional requirements.Once the biomaterial was removed from the catheter, the catheter body appeared to flush as intended.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received , unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: "incident occurred on 20 february 2023.Within 48 hours after insertion, the catheter no longer worked properly: it was impossible to sample blood (no return of arterial blood) and the arterial pressure waveform gets flat resulting in a lack of blood pressure monitoring.Consequence: blood pressure monitored with the armband, allowing secure monitoring, but not sufficient for an intensive care department monitoring (drug therapy).We attempted to replace the catheter but with similar difficulties.".It was reported the patient's condition is "stable".There was no patient injury or medical intervention needed.

• 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: 16582115
• MDR Text Key: 311685533
• Report Number: 3006425876-2023-00254
• 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: 02/21/2023

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 Catalogue Number: SAC-00818-PBX
• Device Lot Number: 71F22J3131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 04/10/2023
• Supplement Dates FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• 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