MAUDE Adverse Event Report: STOCKERT GMBH SMARTABLATE¿ SYSTEM RF GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M-4900-07

Device Problems Loss of or Failure to Bond (1068); Folded (2630)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Concomitant products: carto 3 system (model # m-4800-01, serial # (b)(4)).Navistar ds uni-directional catheter (model # d-1201-20-s, lot # 108245).(b)(4).

Event Description

It was reported that a patient, (b)(6) male, underwent a right sided atrial flutter procedure with a smartablate¿ system rf generator and suffered a skin burn, which required wound management.During the procedure, a skin burn was noticed after ablation.After the procedure was completed, the grounding pad was removed and a blister was noticed on the patient.The patch was folded and was not in complete contact with the patient¿s skin.The burn was noticed above the patch and it measured 4cm x 4cm x 2cm.The second burn was noticed below the patch and it measured 3cm x 1.5cm.The attending physician was notified and the patient was put in consult for wound management.Additional information was received on the event.The patient contact area and the indifferent electrode were properly prepared per the indifferent electrode instructions for use.The indifferent electrode used was at least 124 cm2.The indifferent electrode was positioned at a location on the back as close to the heart as possible on the right flank area of the patient.Upon opening the package for the grounding pad, the conductive gel was present on the indifferent electrode and it was moist.There were no error messages observed on the smartablate generator.Settings during the event include: impedance 140 ohms / power 50 watts / temperature 50 degrees celsius / ablation duration 30-60 seconds.The patient¿s skin burns were classified as first and second degree burns.A silviden topical solution was applied to the burned area.The patient did not require hospitalization due to the event.The patient¿s condition has improved.The physician¿s opinion regarding the cause of this adverse event is that this is caused by patient condition.Post procedure the patch was noted to have pulled back causing an air pocket and area of unattachment to the skin.

Manufacturer Narrative

(b)(4).It was reported that a patient, (b)(6), male, underwent a right sided atrial flutter procedure with a smartablate¿ system rf generator and suffered a skin burn, which required wound management.Generator manufacture stockert could not duplicate the patient injury complaint.Performed functional test, safety test, and sd-card upgrade.The patient injury was due to the patch being folded and not completely in contact with the skin.Upon visual inspection of the generator, physical damage was found at the user interface.Sent back to stockert.Complaint duplicated of physical damage to the user interface and replaced touch screen.Stockert performed functional and safety tests; unit ready for use.Physical damage of user interface did not contribute to the skin burn.The device history record review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer (Section G): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5239361
• MDR Text Key: 31732414
• Report Number: 9612355-2015-00052
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-4900-07
• Device Catalogue Number: M490007
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 124