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

Model Number M-5463-01

Device Problems Device Remains Activated (1525); Device Displays Incorrect Message (2591); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2015

Event Type  malfunction  

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 (b)(4)); thermocool sf catheter (model# d-1313-04-s lot# 17198630l).This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter (afl) procedure with a stockert 70 system and a low temperature without hardware error occurred.It was reported that the stockert 70 system was reading a temperature of 20 degrees when on ablation and dropping to 1 degree on ablation.The ablation cable and catheter were replaced without resolution.Replacing the ablation adapter resolved the issue.The procedure was completed without patient consequence.Upon request additional clarification was received on the event.While ablating and in stand-by mode the demo stockert displayed temperatures as low as 1 degree celsius.The stockert 70 system indicated that it was delivering 35w at temperature at 1c when they stepped on the pedal.Stockert 70 system did not stop delivering energy at this temperature and delivered energy while the temperature was below the cut-off limit.They exchanged map cable, redel cable and radiofrequency (rf) adaptor to the piu.After the rf adaptor cable exchange the temperature went up to 11 degrees with the irrigated catheter and they continued the case.Since the stockert continued to deliver rf while below the cutoff value, this is indicative of a reportable event because it could potentially cause patient injury.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial flutter (afl) procedure with a stockert 70 system and a low temperature without hardware error occurred.Device was evaluated; replacing the ablation adapter resolved the issue.The procedure was completed without patient consequence.No device malfunction was found.The device history record 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-791 11; GM D-79111
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4988642
• MDR Text Key: 23865990
• Report Number: 9612355-2015-00034
• 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
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1