MAUDE Adverse Event Report: TELEFLEX ARROW; ARROW THERMODILUTION BALLOON CATHETER

Model Number AI-07167

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2015

Event Type  Other  

Event Description

While testing the thermodilution balloon prior to insertion through the right internal jugular access sheath, it was noted the balloon did not return to its deflated position in the usual immediate timeframe when the air was manually removed from catheter with the enclosed syringe.The device was removed from the procedure table and the device and packaging were saved from examination.No adverse physical affect to patient.

• Brand Name: ARROW
• Type of Device: ARROW THERMODILUTION BALLOON CATHETER
• Manufacturer (Section D): TELEFLEX; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 5080693
• MDR Text Key: 26011429
• Report Number: MW5056175
• Device Sequence Number: 1
• Product Code: DYG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AI-07167
• Device Catalogue Number: AI-07167
• Device Lot Number: 16F15C007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1