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

Catalog Number 39D76X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Death (1802); Fistula (1862)

Event Date 05/10/2019

Event Type  Death  

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.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a female patient of about (b)(6)-years-old (100 kg) underwent an ablation procedure for persistent atrial fibrillation with a thermocool® smart touch¿ bi-directional navigation catheter and a stockert generator and suffered esophageal fistula that led to death.Post-procedure, the patient developed esophageal fistula.Perforation was not detected during the procedure.No medical/surgical intervention was performed.Extended hospitalization was required due to the patient having epileptic attacks.The patient expired on (b)(6) 2019.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related, the patient had a complex clinical background that contributed to the clinical complication; overweight, diabetes and especially sarcoidosis.Esophageal injury confirmed with autopsy.The stockert generator was used in power control mode with a temperature cut-off at 50 degrees.No error messages were observed on any bwi equipment during the procedure.The force visualization features used included graph, dashboard, vector and visitag.The parameters for stability used with the visitag module were 3mm, time: 3s, force over time: 25%, 3g.The color option used prospectively was tag index (380 posterior, 500 anterior).The carto® 3 system did not indicate to re-zero the thermocool® smart touch¿ bi-directional navigation catheter.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: (1) mfr # 2029046-2019-03240 for product code (b)(4) (thermocool® smart touch¿ bi-directional navigation catheter).(2) mfr # 2029046-2019-03241 for product code (b)(4) (stockert generator).

Manufacturer Narrative

It was reported that a female patient of about 60-years-old (100 kg) underwent an ablation procedure for persistent atrial fibrillation with a thermocool® smart touch¿ bi-directional navigation catheter and a stockert generator and suffered esophageal fistula that led to death.Post-procedure, the patient developed esophageal fistula.Perforation was not detected during the procedure.No medical/surgical intervention was performed.Extended hospitalization was required due to the patient having epileptic attacks.The patient expired on (b)(6) 2019.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related, the patient had a complex clinical background that contributed to the clinical complication; overweight, diabetes and especially sarcoidosis.Esophageal injury confirmed with autopsy.The stockert generator was used in power control mode with a temperature cut-off at 50 degrees.No error messages were observed on any bwi equipment during the procedure.Device evaluation details: based on information provided by the customer, no malfunction were reported as being related to stockert generator.Service was not requested by the customer.As such, the complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.Manufacturer¿s ref #: (b)(4).

Manufacturer Narrative

On 6/18/2019, the manufactured date of the stockert generator was provided as may 15, 2001.Therefore, field device manufacture date.Device manufacture date has been populated.Manufacturer's ref # (b)(4).

• Brand Name: STOCKERT GENERATOR
• Type of Device: SIMILAR DEVICE S7001, PMA # P990071
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8673258
• MDR Text Key: 147149899
• Report Number: 2029046-2019-03241
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 39D76X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO 3 SYSTEM
• Patient Outcome(s): Death
• Patient Age: 60 YR