MAUDE Adverse Event Report: ZELTIQ AESTHEITCS, INC. ZELTIQ APPLICATOR; COOLADVANTAGE APPLICATOR

Model Number	BRZ-AP2-160-000
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); Thrombus (2101)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no reported or suspected device malfunction.No error message occurred during treatment, and the patient completed the coolsculpting treatment with no issue.However, according to the nurse the patient was dual-sculpted on the lower abdomen at a different angle than standard protocol due to an old scar and how the patient's fat displayed.Allergan is currently reviewing treatment logs as part of the device investigation.The reported "unprovoked blood clot" in the patient's abdominal area was assessed as a serious injury which may or may not be related to the use of the coolsculpting device.Treatment logs have been retrieved from the device and are currently being reviewed as part of the device investigation.A supplemental mdr will be submitted upon completion of the investigation.
Event or Problem Description
On (b)(6) 2018 allergan was made aware of a report wherein an (b)(6) female patient who received 4 cycles of coolsculpting treatment to the lower abdomen using a cooladvantage applicator noticed swelling on the upper part of her left leg at three weeks post treatment.Within a few days to a week, the patient noticed her entire left leg had become swollen, which prompted her to consult her primary care physician.The patient's physician advised her to go to the er where ultrasound was performed and no blood clot was seen on the left leg.Ct scan, abdominal scope, colonoscopy were performed, and the physician told the patient that she had an "unprovoked blood clot" in the lower abdomen.The patient was also told that she had "extremely low hemoglobin level." the patient received 3 iron infusions at the hospital, and was subsequently put on blood thinners and iron supplements.The patient had no prior history of deep vein thrombosis, anemia or any circulatory issue.There was no reported or suspected device malfunction.No error message occurred during treatment, and the patient completed the coolsculpting treatment with no issue.However, according to the nurse the patient was dual-sculpted on the lower abdomen at a different angle than standard protocol due to an old scar and how the patient's fat displayed.Allergan is currently reviewing treatment logs as part of the device investigation.The reported "unprovoked blood clot" in the patient's abdominal area was assessed as a serious injury which may or may not be related to the use of the coolsculpting device.Treatment logs have been retrieved from the device and are currently being reviewed as part of the device investigation.A supplemental mdr will be submitted upon completion of the investigation.
Event or Problem Description
On 11/20/2018 allergan was made aware of a report wherein an 81 year old female patient who received 4 cycles of coolsculpting treatment to the lower abdomen using a cooladvantage applicator noticed swelling on the upper part of her left leg at three weeks post treatment.Within a few days to a week, the patient noticed her entire left leg had become swollen, which prompted her to consult her primary care physician.The patient's physician advised her to go to the er where ultrasound was performed and no blood clot was seen on the left leg.Ct scan, abdominal scope, colonoscopy were performed, and the physician told the patient that she had an "unprovoked blood clot" in the lower abdomen.The patient was also told that she had "extremely low hemoglobin level." the patient received 3 iron infusions at the hospital, and was subsequently put on blood thinners and iron supplements.The patient had no prior history of deep vein thrombosis, anemia or any circulatory issue.There was no reported or suspected device malfunction.No error message occurred during treatment, and the patient completed the coolsculpting treatment with no issue.However, according to the nurse the patient was dual-sculpted on the lower abdomen at a different angle than standard protocol due to an old scar and how the patient's fat displayed.Allergan is currently reviewing treatment logs as part of the device investigation.The reported "unprovoked blood clot" in the patient's abdominal area was assessed as a serious injury which may or may not be related to the use of the coolsculpting device.Treatment logs have been retrieved from the device and are currently being reviewed as part of the device investigation.A supplemental mdr will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The device was not available for investigation, but the system log was retreived and reviewed.No device malfunction was identified.The device functioned as designed.A causal relationship between the adverse event and the use of the device cannot be established.

• Brand Name: ZELTIQ APPLICATOR
• Common Device Name: COOLADVANTAGE APPLICATOR
• Manufacturer (Section D): ZELTIQ AESTHEITCS, INC.; 4410 rosewood drive; pleasanton CA 94588
• MDR Report Key: 8148736
• Report Number: 3007215625-2018-00013
• Device Sequence Number: 1406698
• Product Code: OOK
• UDI-Device Identifier: 00816417020018
• UDI-Public: 010081641702001821
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BRZ-AP2-160-000
• Device Catalogue Number: BRZ-AP2-160-000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/04/2019
• 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: Other; Required Intervention