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

Catalog Number M490007

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

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/15/2019

Event Type  Injury  

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.Concomitant products: thermocool® smart touch® sf bi-directional navigation catheter (model# d-1348-04-s, lot# unknown).Covidien electrode patch (model# unknown, lot# unknown).Manufacture reference no: (b)(4).

Event Description

It was reported that a (b)(6) female patient underwent a redo atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and smartablate¿ system rf generator and suffered 3rd degree skin burns requiring no interventions.Post-procedure, the physician discovered in a follow up visit that the patient had 3rd degree skin burns on their back where the indifferent electrode was positioned.No medical/surgical intervention or extended hospitalization was required.Patient¿s outcome was improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure (3rd redo ablation) and patient condition (multiple af ablations affects tissue structure, making it weaker) related.The indifferent electrode patch used was from covidien and is was at least 124 cm.It was placed at a location on the back as close to the heart as possible.The generator settings included 35-40 watts for 4 hours duration.No error messages were observed on any bwi equipment during the procedure.

Manufacturer Narrative

It was reported that a (b)(6) female patient underwent a redo atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and smartablate¿ system rf generator and suffered 3rd degree skin burns requiring no interventions.On 4/16/2019, we received information indicating service was declined.Since service was declined, no product failure analysis can be conducted and no determination of possible contributing factors could be made.In the initial report, the manufacture address was erroneously reported as (b)(4).On 4/26/2019, a manufacturing record evaluation was performed for the finished device and no internal actions were identified.Additionally, the manufacturing date was provided.Device manufacturer date has been updated with 7/11/2017.Manufacturer ref no: (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology dr.; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8515947
• MDR Text Key: 141986055
• Report Number: 2029046-2019-02986
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M490007
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 71