MAUDE Adverse Event Report: ARROW INTERNATIONAL ARROW INTERNATIONAL RADIAL ARTERY CATH KIT

Model Number RA-04122

Device Problems Material Frayed (1262); Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, the pt underwent an attempted arterial line placement by the physician who utilized an arrow international radial artery catheterization set.During this process, there was resistance felt to withdrawal of the guidewire (seldinger technique used), so the entire needle/guidewire assembly was removed.It was noted that the guidewire was frayed at the end upon removal.An x-ray revealed an 6mm linear metallic foreign body within the radial soft tissue of the distal left forearm.

• Brand Name: ARROW INTERNATIONAL RADIAL ARTERY CATH KIT
• Type of Device: RADIAL ARTERY CATH KIT
• Manufacturer (Section D): ARROW INTERNATIONAL ; reading PA 19605
• MDR Report Key: 5764635
• MDR Text Key: 48735911
• Report Number: MW5063187
• Device Sequence Number: 1
• Product Code: DQO
• 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: 06/28/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: RA-04122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR