MAUDE Adverse Event Report: CAREFUSION AVAFLEX ADVANCED VERTEBRAL AUGMENTATION NEEDLE; BONECEMENT VERTEBROPLASTY

Lot Number	0001140024
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was having a vertebroplasty.Radiologist was attempting to reposition the vertebral augmentation needle to add additional cement and the needle would not move.Radiologist made multiple attempts to remove and then tried to remove with the use of hemostats and then the needle broke off with approximately 2 - 2.5 inches above patient's skin.Radiologist contacted an interventional radiologist to discuss case.Plans to transfer the patient to svi for removal on the next morning.The needle entry site was padded with a needle cover and dressed.Patient was given antibiotics prophylactically.Patient procedure was performed at saint vincent infirmary in little rock, ar and interventional radiologist was able to remove the entire needle remaining in the patient (b)(6) 2018.T11 vertebral fracture was reason for the procedure.Route: intravertebral.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: AVAFLEX ADVANCED VERTEBRAL AUGMENTATION NEEDLE
• Common Device Name: BONECEMENT VERTEBROPLASTY
• Manufacturer (Section D): CAREFUSION; veron hills IL 60061
• MDR Report Key: 7450559
• Report Number: MW5076641
• Device Sequence Number: 18858654
• Product Code: NDN
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2018
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 07/31/2018
• Device Lot Number: 0001140024
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 105