MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134801

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

Patient Problems Stroke/CVA (1770); Death (1802); Fistula (1862); No Code Available (3191)

Event Date 04/24/2019

Event Type  Death  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30124933l number, and no internal action related to the reported complaint condition were identified.(b)(6).(b)(4).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: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8663975
• MDR Text Key: 146845017
• Report Number: 2029046-2019-03200
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• 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 Expiration Date: 10/08/2019
• Device Catalogue Number: D134801
• Device Lot Number: 30124933L
• 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; 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