MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20 GA X 8CM; CATHETER, PERCUTANEOUS

Catalog Number	SAC-00820
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "it was found that the wire is bent, prior to use on patient." there was no patient involvement.
Event or Problem Description
It was reported that "it was found that the wire is bent, prior to use on patient." there was no patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, unopened sac set for evaluation.The returned packaging had signs of folding/creasing upon return.The kit was opened to analyze the contents within.Visual analysis revealed the protective tubing had two kinks towards the distal end of the body which aligned with the kinks on the guide wire.The lidstock 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 kinks on the guide wire measured 167 mm and 182 mm from the proximal tip.The guide wire length measured 350 mm, which is within the specification limits of 345-355 mm per guide wire product drawing.The guide wire outer diameter measured 0.516 mm, which is within the specification limits of 0.508-0.533 mm per 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 the undamaged portions were able to pass with little to no resistance.A manual tug test confirmed that the distal and proximal welds were secure and 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.The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The returned packaging had signs of folding/creasing upon return.Two kinks were observed on the guide wire body which aligned with kinks on the protective tubing and packaging.Despite this, 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.

• Brand Name: ARROW ARTERIAL CATH SET: 20 GA X 8CM
• 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: 20409081
• Report Number: 3006425876-2024-00960
• Device Sequence Number: 6517474
• Product Code: DQY
• UDI-Device Identifier: 10801902144079
• UDI-Public: (01)10801902144079(11)211015(17)260930(10)71F21K0668(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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 Expiration Date: 09/30/2026
• Device Catalogue Number: SAC-00820
• Device Lot Number: 71F21K0668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown