MAUDE Adverse Event Report: CAREFUSION AVAFLEX; VERTEBRAL BALLOON SYSTEM

Model Number 371-60014

Device Problems Break (1069); Tip breakage (1638)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994)

Event Date 12/20/2017

Event Type  malfunction  

Event Description

The curved needle was advanced with the intention for crossing the midline, however during torquing the needle, the tip of the needle broke off and remained within the vertebral body.

• Brand Name: AVAFLEX
• Type of Device: VERTEBRAL BALLOON SYSTEM
• Manufacturer (Section D): CAREFUSION; vernon mills IL
• MDR Report Key: 7150673
• MDR Text Key: 96122392
• Report Number: 7150673
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 371-60014
• Device Catalogue Number: AFB1015
• Device Lot Number: 0001071306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2017
• 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: 69 YR
• Patient Weight: 101