MAUDE Adverse Event Report: ARROW ARROW QUICKFLASH RADIAL ARTERY CATHETER; QUICK FLASH RADIAL ARTERY CATH

Model Number REF RA-04220

Device Problems Difficult to Remove (1528); Material Distortion (2977); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2017

Event Type  malfunction  

Event Description

Attempted to place an art-line in a pt who was on epinephrine, vasopressin, and norepinephrine.There was no problem getting through the skin, but when i was trying to withdraw the catheter, the guide wire would not come out.I re-positioned the catheter and guide wire and was still unable to withdraw it.When i finally got the catheter and guide wire out, they were twisted and distorted.Guide wire and catheter are twisted in a corkscrew type shape.

• Brand Name: ARROW QUICKFLASH RADIAL ARTERY CATHETER
• Type of Device: QUICK FLASH RADIAL ARTERY CATH
• Manufacturer (Section D): ARROW; reading PA 19605
• MDR Report Key: 7128157
• MDR Text Key: 95329239
• Report Number: MW5074098
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: REF RA-04220
• Device Lot Number: 14F14K0308
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR