MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL LINE KIT; WIRE GUIDE CATHETER

Catalog Number	AK-04510-S
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the guidewire gets stuck in the introducer.They then retract the guidewire and use the harder side of the tip or put in another line.Additional information: the guide wire was found to be kinked upon removal.The insertion attempts were performed under ultrasound.There was no scar tissue present and there were no issues advancing the wire in the vessel.Arterial blood flow was present prior to advancing the guidewire.The consequence to the patient of the incident was arterial hematoma that requires manual pressure.An inability to gain accurate blood pressure readings until another line could be placed successfully.The patient was reportedly in severe cardiogenic shock.Additional information has been requested from the account and will be added to the follow up report.The patient's current condition is reported as critical but stable , but not reported as a consequence of the incident.The issue was found in 8 different incidents with 8 different patients.Additional complaints are associated: (b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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." a device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable root cause could not be determined from the available information.No further action was required at the time of the report.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: the guidewire gets stuck in the introducer.They then retract the guidewire and use the harder side of the tip or put in another line.Additional information: the guide wire was found to be kinked upon removal.The insertion attempts were performed under ultrasound.There was no scar tissue present and there were no issues advancing the wire in the vessel.Arterial blood flow was present prior to advancing the guidewire.The consequence to the patient of the incident was arterial hematoma that requires manual pressure.An inability to gain accurate blood pressure readings until another line could be placed successfully.The patient was reportedly in severe cardiogenic shock.Additional information has been requested from the account and will be added to the follow up report.The patient's current condition is reported as critical but stable , but not reported as a consequence of the incident.The issue was found in 8 different incidents with 8 different patients.Additional complaints are associated: (b)(4).

• Brand Name: ARROW ARTERIAL LINE KIT
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17698333
• Report Number: 9680794-2023-00695
• Device Sequence Number: 15331141
• Product Code: DQX
• UDI-Device Identifier: 20801902121688
• UDI-Public: 20801902121688
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: AK-04510-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown