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

Catalog Number	SAC-00522
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during inspection, before the procedure, it was observed that the catheter guide wire was tortuous." there was no patient involvement.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one opened sac kit for analysis.The guide wire and protective tubing was returned separated from the catheter.No evidence of use was observed.Visual inspection of the components revealed one kink in the guide wire body.Several creases on the product packaging were also observed.The damage observed is consistent with defects related to storage and shipping.Both welds were present and appeared full and spherical.The packaging additionally clearly states, "do not bend".The guide wire was advanced through the returned catheter and needle, and the undamaged portions were 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.The instructions for use (ifu) provided with this kit warns the user, "precaution: use of excessive force may damage catheter or guidewire.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.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.The returned packaging had severe signs of folding/creasing upon 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 "during inspection, before the procedure, it was observed that the catheter guide wire was tortuous." there was no patient involvement.

• Brand Name: ARROW ARTERIAL CATH SET: 22 GA 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20460357
• Report Number: 3006425876-2024-01015
• Device Sequence Number: 7880688
• Product Code: DQY
• UDI-Device Identifier: 00801902102751
• UDI-Public: (01)00801902102751(11)220308(17)270228(10)71F22C0147(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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 Catalogue Number: SAC-00522
• Device Lot Number: 71F22C0147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown