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

Catalog Number M490007

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

Event Type  malfunction  

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 patient underwent a supraventricular tachycardia (svt) ablation procedure with a smartablate¿ system rf generator and a high temperature issue occurred.It was reported that 35 watts with 55 degree cutoff was programmed on the smartablate¿ system rf generator.The caller stated that the catheter temperature would get to 62 degrees without alarming.The smartablate¿ system rf generator did not alarm or cut off when the temp exceeded the programmed cut off, however, the doctor did come off immediately and discontinued ablation.There were no patient consequences.This issue of the temperature rising above the cut-off temperature limit without alarming has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

On 10/21/2019, it was noticed that the manufacture date was incorrectly reported in the 3500a initial mdr as 6/22/2019.The correct date of manufacture is 9/22/2015 and device manufacture date has been updated accordingly.Manufacturer's ref # (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a smartablate¿ system rf generator and a high temperature issue occurred.It was reported that 35 watts with 55 degree cutoff was programmed on the smartablate¿ system rf generator.The caller stated that the catheter temperature would get to 62 degrees without alarming.The smartablate¿ system rf generator did not alarm or cut off when the temp exceeded the programmed cut off, however, the doctor did come off immediately and discontinued ablation.There were no patient consequences.Device evaluation details: the device was evaluated and no error is found.Device performed within specification.The device was subjected to preventative maintenance, safety and functional testing and all tests passed.No malfunction was found with the device.Complaint was not confirmed; therefore, a manufacturing record evaluation is not required.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: 8722017
• MDR Text Key: 150164139
• Report Number: 2029046-2019-03292
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (y/n): N
• PMA/PMN Number: P990071/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M490007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2019
• Patient Sequence Number: 1