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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. SMARTABLATE¿ SYSTEM IRRIGATION PUMP; SIMILAR DEVICE M490008, PMA # P990071/S017
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BIOSENSE WEBSTER INC. SMARTABLATE¿ SYSTEM IRRIGATION PUMP; SIMILAR DEVICE M490008, PMA # P990071/S017 Back to Search Results
Catalog Number M4900109
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/24/2019
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 that a patient underwent a persistent atrial fibrilation ablation procedure with a smartablate¿ system irrigation pump and a high flow rate deactivation problem occurred.It was reported that during the ablation procedure, the pump was stuck to 8mm instead of 2mm.They switched the smartablate¿ system irrigation pump off and on and the issue resolved, however, at the end of the procedure the screen remained black.There was no patient consequence.The issue of high flow rate deactivation problem is considered an mdr reportable malfunction.
 
Manufacturer Narrative
On 7/5/2019, additional information was received confirming that there was a flow rate problem.The flow which was jammed at 8 ml did not decrease to the minimum flow of 2 ml during the stopped ablation.This issue occurred twice.At the end of the procedure, the pump did not restart and the error 660 displayed on the smartable.Based on the information provided, the event continues to be deemed mdr reportable.Manufacturer¿s ref # (b)(4).
 
Manufacturer Narrative
It was reported that a patient underwent a persistent atrial fibrilation ablation procedure with a smartablate¿ system irrigation pump and a high flow rate deactivation problem occurred.It was reported that during the ablation procedure, the pump was stuck to 8mm instead of 2mm.They switched the smartablate¿ system irrigation pump off and on and the issue resolved, however, at the end of the procedure the screen remained black.There was no patient consequence.On 7/5/2019, additional information was received confirming that there was a flow rate problem.The flow which was jammed at 8 ml did not decrease to the minimum flow of 2 ml during the stopped ablation.This issue occurred twice.At the end of the procedure, the pump did not restart and the error 660 displayed on the smartable.Device evaluation details: the device was evaluated, and no error was found.The reported issue of the pump being stuck at 8mm could not be duplicated.During evaluation, voltage common collector (vcc) was found defective.Replacement of vcc was performed.Device was performed within specification.The device was also subjected to planned maintenance, safety and functional testing; all tests passed.No device malfunction found.Complaint was not confirmed; failure of vcc did not contribute to the customer¿s reported issue of stuck flow rate.The device history record (dhr) was reviewed.It was verified that the device was manufactured in accordance with documented specification and procedures.No internal actions related to the reported complaint were found.Manufacturer¿s ref # (b)(4).
 
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Brand Name
SMARTABLATE¿ SYSTEM IRRIGATION PUMP
Type of Device
SIMILAR DEVICE M490008, PMA # P990071/S017
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
33 technology drive
irvine CA 92618
MDR Report Key8746743
MDR Text Key149669935
Report Number2029046-2019-03364
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM4900109
Was Device Available for Evaluation? No
Date Manufacturer Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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