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 12/02/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® bi-directional navigation catheter and a stockert 70 system when a high temperature issue occurred.During the procedure, the temperature reading on the stockert generator fluctuated erratically.The high temperatures were reported to have exceeded the temperature cut-off.Replacing the catheter with a similar like device resolved the issue and the procedure was completed successfully.This complaint is reportable because device malfunction of this type could potentially contribute to a death or serious injury.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant medical products: thermocool® smarttouch® bi-directional navigation catheter, lot# 17084462m.(b)(4).A serial number was not provided by the customer, so a complete udi can not be given.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a stockert 70 generator and the stockert did not stop delivering radio frequency energy when the temperature cut-off was reached.This event was reported due to patient risk if ablation is not halted when the temperature limit is reached.Corrected information was received that indicated that there was in fact no device malfunction.The temperature on the stockert was fluctuating erratically, however, the stockert did shut-off when the temperature cut-off was reached.The customer did not request service for the 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.(b)(4).The customer did not request service for the device.

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4361157
• MDR Text Key: 5119860
• Report Number: 9612355-2014-00061
• 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: 12/02/2014

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
• Other Device ID Number: (1)4260166370195
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1