MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT; SIMILAR DEVICE S7001, PMA # P990071

Model Number M-5463-320

Device Problems Device Alarm System (1012); Temperature Problem (3022)

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

Event Date 08/25/2015

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.The 'suspected medical device' reported in this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to stockert 70 system approved under pma # p990071.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a stockert j70 rf generator system and a low temperature without an error occurred.The temperature of the smart touch catheter was displaying 5 degree celsius during the ablation.The cable was reconnected and changed but the issue continued.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequence.Additional information was requested to obtain clarification to this complaint.However, no further information has been made available.Based on the information available, this is indicative of a reportable event as the temperature displayed 5 degrees celsius during ablation which is below the minimum temperature allowed to start ablation.This could potentially cause patient injury.

Manufacturer Narrative

Additional information was also received on october 27, 2015 that the stocker did not start ablation when the temperature was reading 5 degrees celsius.It is possible that the temperature displayed 5 degrees celsius after ablation started however it cannot be confirmed.Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes will be added until the biosense webster system is also updated.Therefore the following codes apply: (b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a stockert j70 rf generator system and a low temperature without an error occurred.The issue was resolved by changing the catheter to another one.No device malfunction found.The device history record review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: STOCKERT
• Type of Device: SIMILAR DEVICE S7001, PMA # P990071
• 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: 5075965
• MDR Text Key: 26317193
• Report Number: 9612355-2015-00043
• Device Sequence Number: 1
• Product Code: BXN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-5463-320
• Device Catalogue Number: S7036
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1