MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC RA CATH KIT: 20 GA X 12 CM; WIRE, GUIDE, CATHETER

Catalog Number	NA-04550-X1A
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: er doctor was placing an emergent femoral arterial line as patient was critically ill and they were unable to obtain blood pressure reading.It was a non-sterile procedure as the patient looked like they may code.Ultrasound guidance was used.The doctor tested the wire through the needle, and it was smooth before the procedure.The arterial stick was successful but when they attempted to tread the wire through the needle into the patient, she met resistance.She attempted to pull back the wire but met resistance again.She managed to remove the wire but found that it was uncoiled, and a piece was separated.The ultrasound showed that the end of the wire was in the patient's soft tissue on top of the artery.A cta was done because of the patient's condition, and this confirmed that the wire was not in the vasculature.The wire was left in place on the advice of vascular surgical doctor and the patient was transferred to another hospital because of their critical condition.It was handed over that the patient had the piece of wire in situ, but the team are not aware of what happed after this.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: er doctor was placing an emergent femoral arterial line as patient was critically ill and they were unable to obtain blood pressure reading.It was a non-sterile procedure as the patient looked like they may code.Ultrasound guidance was used.The doctor tested the wire through the needle, and it was smooth before the procedure.The arterial stick was successful but when they attempted to tread the wire through the needle into the patient, she met resistance.She attempted to pull back the wire but met resistance again.She managed to remove the wire but found that it was uncoiled, and a piece was separated.The ultrasound showed that the end of the wire was in the patient's soft tissue on top of the artery.A cta was done because of the patient's condition, and this confirmed that the wire was not in the vasculature.The wire was left in place on the advice of vascular surgical doctor and the patient was transferred to another hospital because of their critical condition.It was handed over that the patient had the piece of wire in situ, but the team are not aware of what happed after this.
Additional Manufacturer Narrative
(b)(4).The customer provided multiple photos for analysis.The complaint of guide wire separated in use can be confirmed from visual inspection of the supplied photos.The first and second photos revealed a complete separation of the core wire and spring coil in the clinical environment.The third photo revealed the lot information from the lidstock.The customer also returned multiple components from the kit, including the catheter, scalpel, chloraprep applicators, and guide wire assembly tubing for analysis.However, the guide wire was not returned for analysis.Visual analysis of the returned components did not reveal any defects or anomalies.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: "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel.Precaution: use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force maydamage catheter or guidewire." the complaint of guide wire separated in use can be confirmed from visual inspection of the supplied photos.The photos revealed a complete separation of the core wire and spring coil in the clinical environment.The customer returned multiple kit components, however the guide wire that was revealed in the supplied customer photos was not returned for investigation.Therefore, verification testing could not be performed since the relevant component to the complaint report was not returned.A device history record review was performed, and no relevant findings were identified.Although the complaint can be confirmed based on the customer provided photos, the probable root cause could not be determined based on the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RA CATH KIT: 20 GA X 12 CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18766055
• Report Number: 9680794-2024-00123
• Device Sequence Number: 11887070
• Product Code: DQX
• UDI-Device Identifier: 30801902117374
• UDI-Public: 30801902117374
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: NA-04550-X1A
• Device Lot Number: 33F23G0147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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.; NOT REPORTED.
• Patient Sex: Female