MAUDE Adverse Event Report: BIOSENSE WEBSTER INC STOCKERT J70 RF GENERATOR; SIMILAR DEVICE S7001, PMA # P990071

Catalog Number S7036

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

The hardware analysis has begun, but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.A device history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a stockert generator and a ¿temperature ¿ too low displayed ¿ no hw error¿ issue occurred.There were no patient consequences.This is mdr reportable under the generator.Merge was performed.Upon initiating ablation at the bottom of the left pulmonary vein, the stockert generator temperature decreased to 6 degrees celsius.Ablation was attempted a 2nd time and the temperature decreased again.Cable was exchanged and ablation was performed at 1 watt.Temperature displayed normally.Ablation was performed at 20 watts and the temperature decreased.Stockert generator was physically ablating while the low temperature error displayed.Smarttouch sf catheter was exchanged and the procedure was completed without patient consequences.This issue is mdr reportable.Generator was set on power control mode.Temperature was noted to be 6 degrees celsius.Stockert generator continued to ablate while the low temperature error displayed.There is no information regarding if the initial temperature prior to ablating was below 10 degrees celsius.

Manufacturer Narrative

On 8/21/2018, the serial number of the stockert j70 rf generator was provided as (b)(4).Manufacturer's ref # (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a stockert generator and a ¿temperature ¿ too low displayed ¿ no hw error¿ issue occurred.It was reported the stockert generator was physically ablating while the low temperature error displayed.The smarttouch sf catheter was exchanged and the procedure was completed without patient consequences.Device evaluation details: it was confirmed that the failure was resolved after replacing the catheter.The stockert generator was checked and there were no problems with the system.The stockert generator operated within the system specification and the unit was ready for use.The device history record (dhr) 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.The manufactured date has been provided.Therefore, device manufacture date has been populated.Manufacturer¿s ref # (b)(4).

• Brand Name: STOCKERT J70 RF GENERATOR
• Type of Device: SIMILAR DEVICE S7001, PMA # P990071
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7721093
• MDR Text Key: 115407945
• Report Number: 2029046-2018-01850
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S7036
• Date Manufacturer Received: 09/05/2018
• Patient Sequence Number: 1