MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20GA X 5CM; CATHETER, PERCUTANEOUS

Catalog Number	SAC-00520
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the wire was found to be kinked.It was found during product preparation before use on a patient.No patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one opened sac set with the swg in its protective tubing for evaluation.The returned packaging had one major crease as the outside packaging was folded upon return.Visual analysis revealed the protective tubing had one kink on the body which aligned with a kink on the guide wire.The lid stock clearly states, "do not bend." the damage observed is consistent with defects related to storage and shipping.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kink on the guide wire measured 114mm from the distal tip.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 0.516mm, which is within the specification limits of 0.508mm-0.533mm per the guide wire product drawing.The guide wire was advanced through a lab inventory catheter.The undamaged portions passed with little to no resistance.Performed per 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 instructions for use (ifu) 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.One kink was observed on the guide wire body and protective tubing.The returned packaging had one major crease from being folded in half prior to return.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.
Event or Problem Description
It was reported that: the wire was found to be kinked.It was found during product preparation before use on a patient.No patient involvement.

• Brand Name: ARROW ARTERIAL CATH SET: 20GA X 5CM
• Common Device Name: 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: 17786985
• Report Number: 3006425876-2023-00897
• Device Sequence Number: 15316884
• Product Code: DQY
• UDI-Device Identifier: 10801902144062
• UDI-Public: 10801902144062
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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 Expiration Date: 09/30/2026
• Device Catalogue Number: SAC-00520
• Device Lot Number: 71F21K2001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown