MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. SMARTABLATE¿ SYSTEM RF GENERATOR (EU); SIMILAR DEVICE M490007, PMA # P990071/S017

Catalog Number M4900107

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

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.(b)(6).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a smartablate¿ system rf generator and a high flow activation problem occurred during ablation.It was reported that the smartablate¿ system rf generator started the ablation even though the smartablate¿ system irrigation pump was on low flow mode.No error messages were displayed on the smartablate¿ system rf generator or the smartablate¿ system irrigation pump.The smartablate¿ system irrigation pump setup was in manual mode.A navistar thermocool catheter was used.No patient consequences were reported.

Manufacturer Narrative

On 4/28/2020, during an internal review of the complaint file along with a quality engineer, it was noticed that with the available information captured in the event description and additional information provided by the customer, it could be confirmed the event is not mdr-reportable and was incorrectly assessed as an mdr reportable malfunction from the beginning.The information available indicated the smartablate pump was in manual-mode.If the smartablate pump is set in manual mode, then the smartablate generator cannot trigger the smart ablate pump to high flow rate and the smartablate generator would continue to ablate.There is no issue with the smartablate pump nor with the smartablate generator.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event and they should both be considered no longer mdr reportable: (1) mfr # 2029046-2020-00349 for product code m4900107 (smartablate¿ system rf generator (eu)).(2) mfr # 2029046-2020-00356 for product code m4900109 (smartablate¿ system irrigation pump (eu)).

Manufacturer Narrative

On 3/13/2020, additional information was received clarifying the correct account name for this incident is (b)(6) university.As such, field "e1.Initial reporter facility name" was changed from "(b)(6)".Manufacturer¿s ref # (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR (EU)
• Type of Device: SIMILAR DEVICE M490007, PMA # P990071/S017
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9783449
• MDR Text Key: 195717285
• Report Number: 2029046-2020-00349
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M4900107
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GENERIC - NAVISTAR THERMOCOOL; SMARTABLATE PUMP KIT-WW