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

Catalog Number S7001

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

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.This stockert 70 system was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).Concomitant products: pentaray navigational catheter, us catalog #: d128208, lot #: 17706237l, carto 3 system, us catalog #: fg540000, serial #:(b)(4).Manufacturer's ref.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a stockert 70 system.While ablating the cti line, it was reported that the foot pedal did not turn off the ablation.The foot pedal was still moving and did not to appear to be stuck.The generator was turned off to stop the ablation.The generator was turned back on and the issue resolved.There was no patient consequence reported.Additional information was received stating that the generator was in power control mode.Temperature cut off was set to 40 degree celsius.The noted power during ablation when the issue occurred was 40 watts.No cut off values were exceeded.The physician turned the power off directly from the generator without attempting to press the stop button.Since the foot pedal did not turn off the ablation, this issue was assessed as a reportable malfunction.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a stockert 70 system.While ablating the cti line, it was reported that the foot pedal did not turn off the ablation.The foot pedal was still moving and did not to appear to be stuck.The generator was turned off to stop the ablation.The generator was turned back on and the issue resolved.There was no patient consequence reported.Additional information was received stating that the generator was in power control mode.Temperature cut off was set to 40 degree celsius.The noted power during ablation when the issue occurred was 40 watts.No cut off values were exceeded.The physician turned the power off directly from the generator without attempting to press the stop button.Repair follow-up was performed and po was not provided.No responses from the customer.Service was declined.Complaint was unable to be confirmed.The device history record (dhr) review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

• Brand Name: STOCKERT 70 SYSTEM
• Type of Device: RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7122042
• MDR Text Key: 95913288
• Report Number: 2029046-2017-01275
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: P990071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/18/2017

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 Catalogue Number: S7001
• Initial Date Manufacturer Received: 11/18/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 11/18/2017
• Supplement Dates FDA Received: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1