MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18 GA X 12CM; CATHETER, PERCUTANEOUS

Catalog Number	SAC-01218
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " we found the product and packaging damaged (crushed) inside the box during the receipt and labeling inspection".This was found prior to use.Therefore no patient harm or injury.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " we found the product and packaging damaged (crushed) inside the box during the receipt and labeling inspection".This was found prior to use.Therefore no patient harm or injury.
Additional Manufacturer Narrative
(b)(4).The customer provided two images showing an unopened arterial kit for analysis.Visual analysis confirmed kinking on the guide wire and protective tubing.Crease marks were also visible on the outer pouch.The customer also returned one, unopened arterial kit for analysis.The outer corrugate packaging was also returned.There is no evidence of a sterility breach on the sample.Visual analysis revealed one major kink towards the distal end of the guide wire body.Kinking was also noted on the protective tubing and the outer pouch in the same approximate location.Microscopic examination confirmed the kinking.This kinking appears consistent with damage due to improper storage/shipping.No other defects or anomalies were observed with the kit nor the outer corrugate packaging.The kink on the guide wire measured 33mm from the distal weld.The guide wire total length measured 339mm, which is within the specification limits of 331mm-340mm per the guide wire product drawing.The guide wire outer diameter measured 0.61mm, which is within the specification limits of 0.61mm-0.64mm per the guide wire product drawing.The guide wire was inserted through the returned catheter body.Minor resistance was encountered at the location of the kink; however, all functional sections of the guide wire passed with little to no issue.Performed per ifu statement, "thread tip of indwelling catheter over spring-wire guide".A manual tug test confirmed that the distal and proximal welds were secure and intact.The manufacturing site was previously consulted regarding the observed failure mode for related complaints.As part of the guide wire manufacturing process, each guidewire is passed through a ring gauge so it is unlikely that this defect would have been present prior to release from the manufacturing site.A device history record review was performed, and no relevant findings were identified.The lidstock on the returned kit was also reviewed.The words "do not bend" are clearly visible on the top and the bottom of the lidstock.The instructions for use (ifu) provided with this kit warns the user, "use of excessive force may damage catheter or spring-wire guide".The customer report of a kinked guide wire prior to use was confirmed through complaint investigation of the returned sample.One kink was observed on the guide wire body.In addition, a fold/crease was observed on the guide wire tubing and the outer pouch in the same approximate location.The guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.The lidstock 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 complaints of this nature.

• Brand Name: ARROW ARTERIAL CATH SET: 18 GA X 12CM
• 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: 19257297
• Report Number: 3006425876-2024-00422
• Device Sequence Number: 6493142
• Product Code: DQY
• UDI-Device Identifier: 00801902102799
• UDI-Public: 00801902102799
• 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): 04/08/2024

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: 04/30/2026
• Device Catalogue Number: SAC-01218
• Device Lot Number: 71F21E2051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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