MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-02 for CELLFINA CK1-EU manufactured by Ulthera, Inc..
[68966199]
Ulthera was able to recreate a very similar effect using a tissue like substance by forcing vacuum pressure loss while the motor module was turned on and blade inserted into the elastomeric septum. With loss of pressure, the tissue capture fell and created a 2-3cm laceration within seconds. The risk report and ifu were reviewed and confirmed to ensure they covered vacuum pressure loss. The returned vacuum handpiece and its associated lid were functionally and visually inspected with the use of a bausch & lomb eye loupe x10, per 1004429tpr "operation 20: component inspections". A perforation of the elastomeric septum was identified. Flash or sink marks were not detected along the surfaces of the vacuum handpiece. The vacuum handpiece was functionally evaluated with the use of a medela dominat 50 per 1004429tpr "operation 50: post procedure vacuum test" and a 40a durometer silicone sheet acted as the tissue simulant material. Assessment was run at -20kpa, -45kpa, -60kpa. Upon activation of medela dominat 50 with a -60kpa vacuum applied, the tissue simulate material acquisition diameter created during treatment was measured, with a calibrated caliper, at 5. 994cm at the 10mm depth with lid 1. The acquisition diameter created with lid 2 at the 10mm depth was measured at 5. 658cm. The tissue simulate material was sufficiently captured within the treatment area, as stated within 1004307psd, "lid / vacuum handpiece shall acquire tissue or other tissue simulant material over a 5 +1/-0 cm diameter circle or 3 cm x 5 cm rectangle at the 6mm/10mm acquisition depth as indicated on the lid when a 40-60 kpa vacuum is applied". The failure mode is inconclusive based on the assessments completed with the components that have been returned. Ulthera concludes that there is no ck1 device malfunction during the treatment and no further investigation of the other devices (medela vacuum pump or motor module) used in the treatment is necessary because the physician subsequently operated without any anomalies. Ulthera is in agreement with the physician that the operator of the foot pedal may have unintentionally bumped the pedal releasing the vacuum pressure or other causes of loss of vacuum occurred.
Patient Sequence No: 1, Text Type: N, H10
[68966200]
During a cellfina procedure, the physician had to increase the pressure of the vacuum in order to have a good vacuum assisted tissue capture using the vacuum handpiece. During a subcutaneous tissue release with the motor module switched on, the vacuum pressure was lost, resulting in a 2-3 cm laceration of the patients skin. The physician speculates the immediate vacuum pressure loss was due to: numerous stabs through the elastomeric septum of the vacuum handpiece may had caused a hole/disruption in the septum that let air through; skin surface too wet; accidental switching off of the vacuum foot pedal. The physician stated that person operating the vacuum foot pedal was not a medical professional, and may have bumped the pedal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00004 |
| MDR Report Key | 6374664 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-02 |
| Date of Event | 2017-01-30 |
| Date Mfgr Received | 2011-02-02 |
| Device Manufacturer Date | 2016-05-13 |
| Date Added to Maude | 2017-03-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KELLIE CERVANTES-WILES |
| Manufacturer Street | 1840 S STAPLEY DRIVE # 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 4803361788 |
| Manufacturer G1 | ULTHERA, INC |
| Manufacturer Street | 1840 S STAPLEY DR STE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85204 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLFINA |
| Generic Name | CELLFINA STERILE DISPOSABLE KIT |
| Product Code | OUP |
| Date Received | 2017-03-02 |
| Returned To Mfg | 2017-02-22 |
| Model Number | CK1-EU |
| Lot Number | 46013651 |
| Device Expiration Date | 2018-05-13 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTHERA, INC. |
| Manufacturer Address | 1840 S STAPLEY DRIVE STE 200 MESA AZ 85204 US 85204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2017-03-02 |