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

Catalog Number	SAC-00520
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during the product receipt and labeling inspection, we discovered a damaged package and the catheter and swg were kinked.".
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis, the photo shows an unopened sac kit with the packaging, protective tubing, and guide wire appearing kinked.The customer returned one, unopened sac kit for analysis.No signs of use were observed.Visual analysis revealed the returned packaging and protective tubing had signs of folding/creasing upon return.The damage observed is consistent with defects related to storage and shipping.The lidstock clearly states, "do not bend." the kit was opened to analyze the contents within, and no defects or anomalies on the guide wire.Microscopic examination confirmed the distal and proximal welds were secure and intact.The guide wire length measured 350 mm, which is within the specification of the guide wire product drawing.The guide wire outer diameter measured 0.513 mm, which is within the specification of the guide wire product drawing.The guide wire 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.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." the guide wire was advanced through the returned catheter and was able to pass with little to no resistance.A manual tug test confirmed that the distal and proximal welds were intact.The guide wire product drawing was reviewed as part of this complaint investigation.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 damaged device was confirmed through complaint investigation of the returned sample.The returned packaging and protective tubing had signs of folding/creasing upon return; however, no defects or anomalies were observed on the guide wire.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 the product receipt and labeling inspection, we discovered a damaged package and the catheter and swg were kinked.".

• Brand Name: ARROW ARTERIAL CATH SET: 20 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: 20006486
• Report Number: 3006425876-2024-00808
• Device Sequence Number: 4376208
• Product Code: DQY
• UDI-Device Identifier: 10801902144062
• UDI-Public: (01)10801902144062(11)220427(17)270331(10)71F22D1730(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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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-00520
• Device Lot Number: 71F22D1730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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
• Patient Sex: Unknown