MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 22 GA X 5CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-00522

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "the catheter was found to be kinked prior to use on patient.".

Event Description

It was reported that: "the catheter was found to be kinked prior to use on patient.".

Manufacturer Narrative

Qn# (b)(4).The customer returned one, unopened arterial cath set for analysis.Visual analysis revealed the packaging had major folds and creases towards both the distal and proximal ends with two major folds observed overlapping the catheter and guide wire assembly.The protective tubing surrounding the guide wire was also kinked.The lidstock clearly states, "do not bend." the damage observed is consistent with defects related to storage and shipping.It is likely both the catheter and guide wire were kinked as a result of the folds in the packaging.The package was opened to analyze the contents within.The guide wire was removed from within the catheter and a total of four kinks were observed on the guide wire.Microscopic examination confirmed the damage and revealed that the distal and proximal welds of the guide wire were secure and intact.The kinks on the guide wire measured 39 mm, 51 mm, 71 mm, and 100 mm from the proximal tip.The guide wire length measured 349 mm, which is within the specification limits of 345-355 mm per the guide wire product drawing.The guide wire outer diameter measured 0.526 mm, which is within the specification limits of 0.508-0.533 mm per the guide wire product drawing.The guide wire was advanced through the returned catheter, and it was able to pass with little to no resistance.Performed per instructions for use (ifu) statement, "thread tip of catheter over guidewire.Precaution: allow sufficient guidewire length to remain exposed at hub end of catheter to maintain firm grip on guidewire.Grasping near skin, advance catheter into vessel." a manual tug test confirmed that the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The provided with this kit warns the user , "do not use if package is damaged".The lidstock was reviewed as part of this complaint investigation.The words "do not bend" are clearly visible on the front of the lidstock.An engineering change order was implemented in april 2017 to update the product labeling to clearly inform the customer to not bend the product and is intended to reduce the potential for product damage.The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Four kinks were observed on the guide wire body.The returned packaging had multiple creases from being folded at the distal and proximal ends likely resulting in the damage observed on the protective tubing, catheter, and the guide wire within.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.The packaging clearly states, "do not bend." based on the customer description and the sample received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATH SET: 22 GA X 5CM
• 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: 18992988
• MDR Text Key: 338907716
• Report Number: 3006425876-2024-00309
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902102751
• UDI-Public: 00801902102751
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/04/2024

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-00522
• Device Lot Number: 71F23D2741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2023
• 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