MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW; WIRE, GUIDE, CATHETER

Model Number	IPN921747
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Arterial line required replacement due to damped waveform.Provider located axillary artery for new arterial line placement.During procedure, blood flow was obtained, and guidewire was inserted.Provider met resistance and attempted to remove guidewire and reassess insertion needle placement.Provider unable to remove guidewire without resistance.Provider removed guidewire and insertion needle simultaneously "springy" end of guidewire had unwound and was snagged within insertion needle.

• Brand Name: ARROW
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 20912626
• Report Number: 20912626
• Device Sequence Number: 8600191
• Product Code: DQX
• UDI-Device Identifier: 10801902200454
• UDI-Public: (01)10801902200454
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2024
• Report Date (Section F): 10/16/2024

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 Model Number: IPN921747
• Device Catalogue Number: ASK-04510-HFH4
• Device Lot Number: 33F24C0420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 10/16/2024