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

Model Number M490008

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

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.Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a smartablate¿ system irrigation pump (us) and a high flow activation problem occurred.It was reported that the wheel for the flow on the smartablate¿ system irrigation pump (us) would not move when they were delivering radiofrequency (rf) therapy.The caller stated that they stopped ablation, manually moved the wheel and that resolved the issue.There was no report of patient consequence.The sales representative was not present when the event occurred and reported it was probably an av node ablation.The staff stated that they tried to turn the wheel manually and could not move it (which is normal.) later an afib ablation was done without an issue.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a smartablate¿ system irrigation pump (us) and a high flow activation problem occurred.It was reported that the wheel for the flow on the smartablate¿ system irrigation pump (us) would not move when they were delivering radiofrequency (rf) therapy.The caller stated that they stopped ablation, manually moved the wheel and that resolved the issue.There was no report of patient consequence.Product investigation details: the product investigation has been completed.A service and repair follow-up was performed with the customer, and it was determined that the device was not returned/shipped for service by the customer.As such, the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#: (b)(4).

• Brand Name: SMARTABLATE SYSTEM IRRIGATION PUMP (US)
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10113443
• MDR Text Key: 202034039
• Report Number: 2029046-2020-00646
• 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: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• 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
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1