MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT 70 RF GENERATOR; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Model Number M-5463-01

Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762)

Event Date 02/12/2015

Event Type  Injury  

Event Description

It was reported that a patient, (b)(6), male, underwent an atrial flutter (afl) procedure with a stockert 70 system and received an electrical shock, became asystolic and then went into atrial fibrillation which required hemodynamic support.An ablation catheter that was already in the patient¿s heart was plugged into a reprocessed mapping cable which was already connected to the patient interface unit (piu).Upon connection, there were large amplitude spikes at about 100 ms and signal saturation was noticed throughout all electrocardiograms (ecg), electrograms (egm) and monitoring channels making it unable to see any ecg signal.In addition, there was a "current leakage" alert on the carto 3 system.The patient, who was moderately sedated, received an electric shock for six seconds when the catheter was connected to the cable.It was then noted that the patient became asystolic for approximately three seconds and then spontaneously went into atrial fibrillation.The issue ceased when the cable was detached from the catheter.The cable was replaced and the same catheter was reconnected to the new cable without any errors appearing.Hemodynamic support in the form of vasopressors for approximately 30 minutes was provided to the patient following the incident.The patient was cardioverted and the procedure was continued with no further issues with the patient.The patient also required an overnight stay that was not anticipated.The patient was reported to be in stable condition and was released the next day.The right atrium was about to be mapped and the patient had an existing dual chamber pacemaker that did not capture for a few seconds afterword and then reverted to magnet mode.It was examined afterwards and was found to be in working order.The physician believes there was current transfer from the piu through the ablation catheter.

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: coolflow pump (model# m-5491-02 serial# (b)(4)).This stockert was manufactured before september 24, 2014; therefore no udi is applicable for this product with serial number (b)(4).(b)(4).The products involved were the ez steer thermocool sf nav catheter, c3 interface cable ¿ therapeutic, carto 3 system and stockert system.It is currently unknown which product contributed to the event and a complete investigation will be done to determine the causative device.

Manufacturer Narrative

(b)(4).It was reported that a patient, (b)(6), male, underwent an atrial flutter (afl) procedure with a stockert 70 system and received an electrical shock, became asystolic and then went into atrial fibrillation which required hemodynamic support.The device was evaluated and no error was found.The device was within specifications.The device was subjected to preventive maintenance, safety and functional testing and all tests passed.No malfunction found on device.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: STOCKERT 70 RF GENERATOR
• Type of Device: RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE
• 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-79 111; GM D-79111
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4588106
• MDR Text Key: 5481559
• Report Number: 9612355-2015-00009
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071
• 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: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-5463-01
• Device Catalogue Number: S7001
• Other Device ID Number: (1)4260166370195
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85