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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN¿ PUMP; NGEN PUMP
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BIOSENSE WEBSTER INC NGEN¿ PUMP; NGEN PUMP Back to Search Results
Catalog Number UNK_NGEN PUMP
Device Problems Decreased Pump Speed (1500); Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2023
Event Type  malfunction  
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with an unknown ngen¿ pump and a low flow without error issue occurred.It was reported that there was a lack of error message while the qdot catheter has been plugged in to the ngen¿ and to the carto.There was no visible error while there was no irrigation with no visible error on the ngen¿ and on the carto.The catheter was introduced in the left atrium and due to this absence of irrigation, blood has been coming from out of the irrigation canal due to high blood pressure on the heart (normal behavior).It has to get an error on the ngen¿ in this case and there was no error.He had to replace the qdot catheter to manage to complete the case during a persistant afib.There was ten minutes of delay (during the set-up of the case).There were no patient consequences.The low flow without error message issue is mdr reportable to the us fda.
 
Manufacturer Narrative
Initial reporter phone : (b)(6).Multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.Since no serial number was provided, no manufacturer record evaluation could be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
 
Manufacturer Narrative
On 09-jun-2023, additional information was received from the customer and it was confirmed that service was not needed on the pump.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
 
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Brand Name
NGEN¿ PUMP
Type of Device
NGEN PUMP
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER, INC.
560 cottonwood drive
milpitas CA
Manufacturer Contact
kate karberg
31 technology dr
irvine, CA 92618
3035526892
MDR Report Key16695587
MDR Text Key312949054
Report Number2029046-2023-00746
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P990071/S037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_NGEN PUMP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/09/2023
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NGEN RF GENERATOR; UNK_CARTO 3; UNK_QDOT MICRO; UNK_QDOT MICRO
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