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

Catalog Number	M490008
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
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.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported a patient underwent a atrial fibrillation (afib) ablation procedure with a smartablate¿ system irrigation pump and a high flow activation problem occurred during ablation.It was reported that the thermocool® smart touch¿ bi-directional navigation catheter was not irrigating correctly.After starting the first ablation pass the temperature was high.The thermocool® smart touch¿ bi-directional navigation catheter was replaced but the issue persisted.The customer checked the smartablate¿ system irrigation pump and was noticed that the pump¿s high-flow was not working properly.The smartablate¿ system irrigation pump was replaced with one from another room and the issue resolved.The issue of high flow activation problem has been assessed as an mdr reportable malfunction.
Additional Manufacturer Narrative
It was reported a patient underwent a atrial fibrillation (afib) ablation procedure with a smartablate¿ system irrigation pump and a high flow activation problem occurred during ablation.It was noticed that the pump¿s high-flow was not working properly.Device evaluation details: the device was evaluated and no error is found.Device is performed within specification.The device was subjected to planned maintenance, safety and functional testing and all tests passed.No malfunction was found on device.The certificate of conformance was reviewed.It was verified that the device was manufactured in accordance with documented specification and procedures.The customer complaint was not confirmed.Manufacturer¿s ref # (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: 8508892
• Report Number: 2029046-2019-02974
• Device Sequence Number: 13898325
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/22/2019

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 Catalogue Number: M490008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 07/10/2019
• 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: SEE SECTION H10.