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

Model Number M490008

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient, underwent an ablation procedure for atrial fibrillation (afib) with a smartablate¿ system irrigation pump, and an undetected air bubbles issue occurred.During ablation, when the tubing was opened, the tubing was cloudy, even when flushed.Additionally, the tubing had many tiny bubbles and large bubbles to pass through the pump, without setting off the sensor.There was no report of patient consequence.Follow up is in progress to clarify if the pump did not detect the bubble during flushing.The observed cloudy tubing has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The undetected air bubbles issue has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient, underwent an ablation procedure for atrial fibrillation (afib) with a smartablate¿ system irrigation pump, and an undetected air bubbles issue occurred.During ablation, when the tubing was opened, the tubing was cloudy, even when flushed.The device was evaluated, and no error/failure was found.Device performed within specification.The device was subjected to preventative maintenance, safety, and functional testing and all tests passed.No malfunction is found on device.A manufacturing record evaluation was performed for the finished device and no internal actions were identified.Manufacture reference no: (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM IRRIGATION PUMP
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9471171
• MDR Text Key: 200800569
• Report Number: 2029046-2019-03997
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• 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
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M490008
• Device Catalogue Number: M490008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE IRR TUBE SET