MAUDE Adverse Event Report: HOLOGIC INC. ADIANA PERMANENT CONTRACEPTION SYSTEM

Catalog Number	A1000
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Death (1802); Pregnancy (3193)
Date of Event	07/04/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot and serial number of the disposable devices not provided by the complainant, therefore the expiration dates of the disposable adiana devices are not known.Serial number of the adiana generator not provided by the complainant.Neither the devices nor radio frequency generator are being returned; therefore, a failure analysis of this adiana system can not be completed.Lot and serial numbers not provided by the complainant; therefore, the manufacture dates of the disposable devices and radio frequency generator are not known.Device history record (dhr) review was unable to be conducted for the disposable device or the radio frequency generator as the identification numbers were not provided by the complainant.(b)(4).
Event or Problem Description
Following an adiana procedure for permanent contraception in the year 2013, the patient was told "she could get pregnant".Sometime in the year 2015 the patient presented to the hospital experiencing "abdominal pain".A pregnancy test revealed that she was "pregnant" and the physician did not tell her that anything was wrong and she was discharged home.Approximately two weeks later at (b)(6) gestation, the patient had elevated blood pressure and no fetal movement was detected.The physician performed an emergency caesarean section (c-section).The physician stated there was no amniotic fluid and that is why her baby was not viable.

• Brand Name: ADIANA PERMANENT CONTRACEPTION SYSTEM
• Common Device Name: ADIANA PERMANENT CONTRACEPTION SYSTEM
• Manufacturer (Section D): HOLOGIC INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 5574622
• Report Number: 1222780-2016-00093
• Device Sequence Number: 423000
• Product Code: KNH
• Combination Product (Y/N): N
• PMA/510(K) Number: P070022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: A1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2016
• Initial Report FDA Received Date: 04/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention