MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. SMARTABLATE¿ SYSTEM RF GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMARTABLATE GENERATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Fistula (1862)

Event Date 04/24/2019

Event Type  Death  

Manufacturer Narrative

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.The manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.(b)(6).Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: mfr # 2029046-2019-03200 for product code d134801 (thermocool® smart touch® sf bi-directional navigation catheter).Mfr # 2029046-2019-03201 for product code unk_smartablate generator (smartablate¿ system rf generator).

Event Description

It was reported that a patient underwent an ablation procedure for paroxysmal atrial fibrillation (paf) with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator and suffered esophageal fistula (requiring surgical intervention) cerebrovascular accident and death.The patient underwent the ablation procedure on (b)(6) 2019.On (b)(6) 2019, the patient had to be urgently transported to another hospital upon suspicion of esophageal injury and air embolism due to left atrial perforation.Surgical closure of the left atrium was successfully performed; however, patient¿s condition worsened, and was declared in vegetative state.The smartablate¿ system rf generator was used in power control mode during the case.No further information is available at the time.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.Biosense webster inc.Has reviewed the event details and it was determined to code the "vegetative state¿ as "death".

Manufacturer Narrative

On 6/12/2019, additional information about the event was received.It was indicated that the patient underwent the ablation procedure on (b)(6) 2019.The left atrium underwent box isolation of the inferior common pulmonary veins.An acunav ultrasound catheter was also used during the procedure.The cause of the left atrial perforation is unknown.Manufacturer¿s ref # (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8663974
• MDR Text Key: 146889268
• Report Number: 2029046-2019-03201
• Device Sequence Number: 1
• Product Code: LPB
• 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
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMARTABLATE GENERATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 06/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACUNAV 8F-90; AGILIS; CIRCLE ELECTRODE CATHETER; GENERIC - ESOPHASTAR; INTRODUCER; PENTARAY NAV ECO 7FR, D, 2-6-2; SHEATH; SL0; SL1
• Patient Outcome(s): Death; Required Intervention