MAUDE Adverse Event Report: CAREFUSION AVAMAX PLUS UNIVERSAL PROCEDURE TRAY; CEMENT, BONE, VERTEBROPLASTY

Model Number VMX00CT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Embolism (1829); Paralysis (1997); Weakness (2145)

Event Date 03/03/2015

Event Type  Injury  

Event Description

(b)(4).During the kyphoplasty procedure, cement leaked posteriorly into the spinal canal.The sales representative noted that approximately 7cc of cement were injected, and approximately 3cc of the 7cc of cement leaked into the spinal canal.The procedure was stopped, imaging (mri) was performed and a laminectomy procedure followed.Post the procedure(s), the patient experienced bilateral lower extremity weakness/paralysis without paresthesia.The sales rep (on behalf of the provider) contacted carefusion r&d inquiring about the thermodynamic properties of the bone cement to have an understanding of how it might react in the spinal canal.It was communicated that per the instructions for use (ifu), ¿the completion of polymerization occurs in the patient and is an exothermic reaction with considerable liberation of heat.According to the iso 5833 standard, the temperature can be as high as 203°f (95°c).The long-term effect of the heat produced along with the resulting tissue damage is not known.¿at this time, customer advocacy has not been apprised of the patient¿s current status.(b)(6) 2015- first request for additional information, awaiting response.

Manufacturer Narrative

(b)(4).Follow up emdr will be submitted if further information becomes available.

Manufacturer Narrative

(b)(4).A complaint sample was not provided for evaluation.Consequently, the investigation was not able to determine any contribution the actual complaint sample had on the reported failure mode.Likewise, the investigation was not able to identify any probable root cause.A review of applicable dhr records did not identify any issue that may have contributed to the reported failure mode.A review of complaint data from (b)(6) 2013 to (b)(6) 2015 did not detect an adverse trend.Based on the results, the investigation was not able to identify any probable root cause for the reported failure.There was no identifying contribution from any manufacturing aspect that may have contributed to the reported failure mode.Since no root cause or contributing factor was identified from the complaint investigation, the investigation did not identify any corrective or preventive actions for the reported failure mode.This complaint will be entered into the complaint trending system and track/trended for future occurrences.

• Brand Name: AVAMAX PLUS UNIVERSAL PROCEDURE TRAY
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 400 east foster rd; mannford 74044
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4616283
• MDR Text Key: 16848119
• Report Number: 1625685-2015-00172
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: VMX00CT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 84 YR