MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18GA X 16CM; CATHETER, PERCUTANEOUS

Catalog Number	SAC-01618
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "presence of kinking in the guide wire." the patient was reported as fine, there was no patient harm or consequence.
Additional Manufacturer Narrative
(b)(4), the report that the guide wire kinked during use was not confirmed through complaint investigation of the returned sample.The customer returned one, arterial catheter for analysis.The guide wire was not returned.Visual analysis revealed a kink towards the distal end of the catheter, and the customer confirmed they were aware of this defect.A device history record review did not identify any manufacturing related issues.Based on the customer report and the sample received, the probable cause of guide wire kinking could not be determined based upon the information provided and without the guide wire being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "presence of kinking in the guide wire." the patient was reported as fine, there was no patient harm or consequence.

• Brand Name: ARROW ARTERIAL CATH SET: 18GA X 16CM
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19728334
• Report Number: 3006425876-2024-00683
• Device Sequence Number: 8207288
• Product Code: DQY
• UDI-Device Identifier: 00801902102829
• UDI-Public: (01)00801902102829(11)220823(17)270731(10)71F22H2040(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: SAC-01618
• Device Lot Number: 71F22H2040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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