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

Catalog Number M490008

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

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 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.

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
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8508892
• MDR Text Key: 145960006
• Report Number: 2029046-2019-02974
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M490008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE SECTION H10.