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
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).
Event or Problem Description
Description update: the catheter was kinked.The issue was detected during use on the patient.The patient was reported as fine, there was no patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).Section b.5.-event description amended.The customer returned one, arterial catheter for analysis.The guide wire was not returned.No obvious signs of use were observed.Visual analysis revealed a kink towards the distal end of the catheter.The kink in the catheter measured 59 mm from the distal tip.The inner diameter of the catheter body measured 0.69 mm, which is within the specification limits of "the inner diameter of the catheter at the distal tip specifies, to a depth of at least 2 mm" per catheter product drawing.The catheter body length measured 163 mm, which is within the specification limits of 162-166 mm per catheter product drawing.The catheter was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "thread tip of catheter over guidewire." a lab inventory 0.635 mm guide wire (measured 0.596 mm) was threaded through the returned catheter and was able to advance through with little to no resistance.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution, " 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.Warning: do not use excessive force in removing catheter." the report that the catheter kinked during use was confirmed through complaint investigation of the returned sample.Visual analysis revealed a kink towards the distal end of the catheter.Despite the damage, the catheter met all relevant dimensional and functional requirements.A device history record review did not identify any manufacturing related issues.Based on the condition of the catheter and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19728418
• Report Number: 3006425876-2024-00738
• Device Sequence Number: 8291032
• 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): 07/10/2024

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: 07/10/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/18/2024
• 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
• Patient Sex: Unknown