MAUDE Adverse Event Report: ULTHERA, INC., MERZ DEVICE INNOVATION CENTER THE CELLFINA SYSTEM

Model Number CK-1

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the actual device could not be performed as the blade was discarded by the practice.The packaging of the device was also discarded by the practice and the lot number could not be obtained despite attempts on (b)(6) 2019.The practice provided a photograph of a cellfina microblade assembly showing the blade disconnected from the shaft thus confirming the issue.The root cause of the condition of bent blade is unknown, and based on information received from the reporter the blade was broken off the shaft when the user manipulated the blade.The instructions for use for the cellfina system state: "warning: visually inspect the microblade assembly prior to and during use.Discard the microblade assembly immediately if there are any signs of damage; including, but not limited to, bent blades, damaged blades, or bent blade shafts.Do not attempt to straighten either the blade or the blade shaft." a review of the complaint trend analysis for the reported issues of "blade bends" and "blade breaks" found the trends to be within acceptable levels and will continue to be monitored.No additional information is available at this time.Should additional information become available, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019, uthera received a report from a practice stating that a blade within a cellfina kit was slightly bent prior to commencing treatment on a patient.The treatment provider determined that the bend was not severe enough to warranty stopping treatment and attempted to perform a release.The doctor reported that the blade entered the patient's skin; however, did not reach the desired depth.The blade was removed for examination and observed to be more bent than it was prior to the release.The doctor then attempted to realign/bend the blade straight manually and the blade tip broke off.A new kit was then used to complete treatment without issue.The doctor emphasized that the patient did not experience an adverse event related to the issue, and does not anticipate any difficulties during the healing process.The packaging and kit/blade were discarded after use so the lot number of the kit is unknown and the device is not available to be returned for evaluation.No additional information is available at this time.

• Brand Name: THE CELLFINA SYSTEM
• Type of Device: CELLFINA SYSTEM
• Manufacturer (Section D): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• Manufacturer (Section G): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• Manufacturer Contact: jessica ward dykstra ; 1840 south stapley drive; suite 200; mesa, AZ 85204 ; 4803361457
• MDR Report Key: 8655775
• MDR Text Key: 202058770
• Report Number: 3006560326-2019-00009
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CK-1
• Device Catalogue Number: 5036030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other