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

Model Number M-5463-01

Device Problem Overheating of Device (1437)

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

Event Date 06/09/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a stockert 70 generator, and a reportable temperature error device malfunction occurred.During the case, the temperature reading from the concomitant ablation catheter read 48 degrees celsius during ablation.However, the user had set the stockert to a cut-off temperature of 40 degrees, and the stockert did not shut off when the temperature reached 48 degrees.This event is reportable because the generator did not stop ablation when the temperature cut-off was reached.Bwi became aware of additional information and reassessed the complaint as a reportable stockert complaint on (b)(4) 2014.Thus, the awareness date has been reset.There appear to have been deviations in the reported procedure and the typical default cut-off temperature bwi recommended settings for a stockert generator.The hardware investigation is pending.

Manufacturer Narrative

Device evaluation is pending.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant products: thermocool® smarttouch® uni-directional navigation catheter (model# d-1336-02-s, lot# 16102935m).(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a stockert 70 generator, and a reportable temperature error device malfunction occurred.The investigational analysis has been completed; follow-up was performed and service was declined.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 ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3971096
• MDR Text Key: 4753791
• Report Number: 9612355-2014-00033
• 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: 06/09/2014

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: M-5463-01
• Device Catalogue Number: S7001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 07/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1