MAUDE Adverse Event Report: BIOSENSE WEBSTER INC STOCKERT 70 GENERATOR; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Catalog Number S7001

Device Problems Issue With Displayed Error Message (2967); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2017

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.(b)(4).

Event Description

It was reported that a patient underwent a supraventricular tachycardia procedure with a stockert 70 system and a low temperature issue occurred.When ablation was started the stockert generator showed a "low temp" error.The thermocool, sf catheter was changed and the procedure continued.The procedure was completed with no patient consequence.Additional information was received on the event.The stockert was connected to the carto 3 system.The generator was in power control mode with a high temperature cutoff of 42°c.During the issue, the noted power was 30 watts and the initial temperature was about 30°c.However, when the initial temperature was below 10°c (the allowed temperature for generator to start the ablation) and showed a low temperature error, the stockert still allowed ablation.Therefore, this event is mdr reportable.If the generator reads a lower temperature than the allowed temperature for generator to start the ablation (10°c), and still starts the ablation, then this could potentially cause patient injury.Multiple attempts have been made to obtain further clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

In the original 3500a report it was reported that the hardware investigation had begun and when the investigation would be completed, a supplemental 3500a report would be submitted.Multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.Since no serial number was provided, no device history record (dhr) review could be performed.Manufacturer's ref.No: (b)(4).

• Brand Name: STOCKERT 70 GENERATOR
• Type of Device: RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology dr; irvine CA 92618
• Manufacturer (Section G): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer Contact: evgeniya degnera ; 33 technology dr; irvine, CA 92618 ; 909839-723
• MDR Report Key: 6867656
• MDR Text Key: 86642102
• Report Number: 9612355-2017-01001
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P990071
• 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: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S7001
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1