MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20 GA X 8CM; CATHETER PERCUTANEOUS

Catalog Number SAC-00820-PBX

Device Problem Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported during insertion of the catheter over the guide, it was observed that the guide was unravelling.Another device was used.Additional information was requested but not available at the time of this report.

Manufacturer Narrative

(b)(4).The customer returned ten unopened sac kits for analysis.Visual analysis revealed no obvious defects or anomalies in any of the returned kits.The customer reported that the damage was found during use on the patient.Therefore, it is being assumed that the ten unopened kits returned for analysis were representative samples.The kits were opened to further analyze the components.In one kit, the guide wire length measured 350mm, which is within the specification limits of 345mm-355mm per the guide wire product drawing.The guide wire outer diameter measured 0.515mm, which is within the specification limits of 0.508mm-0.533mm per the guide wire product drawing.Dimensional inspection of the guide wires in the remaining kits were also within the specification limits.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which states "insert tip of guidewire through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle)." in all the returned kits, the guide wire was inserted through a laboratory 20ga introducer needle.The guide wires were able to pass through the needles with little to no resistance.A manual tug test confirmed that the distal and proximal welds were secure and intact in all returned kits.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "precaution: 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 an unraveled guide wire could not be confirmed through investigation of the returned samples.The customer returned ten representative samples; however, the actual complaint sample was not returned for evaluation.The representative guide wires met all visual, dimensional, and functional requirements.A device history record review did not reveal any relevant findings.Based on the customer report and without the reported sample, the potential root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported during insertion of the catheter over the guide, it was observed that the guide was unravelling.Another device was used.Additional information was requested but not available at the time of this report.

• Brand Name: ARROW ARTERIAL CATH SET: 20 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: 17604642
• MDR Text Key: 321757817
• Report Number: 3006425876-2023-00818
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093050
• 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: 08/01/2023

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-00820-PBX
• Device Lot Number: 71F23A1637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• 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