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

Model Number	M490008
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9471171
• Report Number: 2029046-2019-03997
• Device Sequence Number: 19481391
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P990071/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/15/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE IRR TUBE SET