MAUDE Adverse Event Report: CAREFUSION AVAMAX PLUS; BONECEMENT VERTEBROPLASTY

Catalog Number VMX00CT

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

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

Event Date 04/17/2018

Event Type  Injury  

Event 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: AVAMAX PLUS
• Type of Device: BONECEMENT VERTEBROPLASTY
• Manufacturer (Section D): CAREFUSION; veron hills IL 60061
• MDR Report Key: 7450559
• MDR Text Key: 106722807
• Report Number: MW5076641
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10885403002113
• UDI-Public: 10885403002113
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: VMX00CT
• Device Lot Number: 0001158648
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 105