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

Model 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	05/12/2020
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.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 or Problem 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.
Additional 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)
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10113443
• Report Number: 2029046-2020-00646
• Device Sequence Number: 16606310
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/12/2020

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
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1