DECANAV ELECTROPHYSIOLOGY CATHETER R7D282CT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-09 for DECANAV ELECTROPHYSIOLOGY CATHETER R7D282CT manufactured by Biosense Webster Inc.

Event Text Entries

[188862875] Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacture reference no: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[188862876] It was reported that a male patient underwent paroxysmal atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis. During an afib procedure at the conclusion of pulmonary vein isolation, a pericardial effusion was diagnosed via (ice) intracardiac electrocardiogram. A pericardiocentesis was performed by the physician to remove 500ml of fluid. The caller reported that the physician stated that the decanav catheter was the cause. The patient was stable at the time of the call and was transferred to the intensive care unit (icu) for observation. The patient was observed for two days and had recovered. The event occurred during the use of biosense webster inc. (bwi) products. Transseptal was performed with baylis transseptal needle. Ablation was performed prior to discovery of the effusion. There was no evidence of steam pop. The flow settings on an irrigated catheter (unspecified) was 2ml. There were no error messages on biosense webster equipment. Graph, dashboard and visitag features were used for force visualization. Visitag parameters were 3mm, 3 seconds, 25%, 3 grams with time for coloring.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029046-2020-00372
MDR Report Key9805102
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-09
Date of Report2020-02-13
Date of Event2020-02-13
Date Mfgr Received2020-02-13
Device Manufacturer Date2020-01-15
Date Added to Maude2020-03-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. GABRIEL ALFAGEME
Manufacturer Street31 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone949789-868
Manufacturer G1BIOSENSE WEBSTER INC (JUAREZ)
Manufacturer StreetCIRCUITO INTERIOR NORTE 1820PARQUE INDUSTRIAL SALVACAR
Manufacturer CityJUAREZ 32599
Manufacturer CountryMX
Manufacturer Postal Code32599
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDECANAV ELECTROPHYSIOLOGY CATHETER
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Product CodeDRF
Date Received2020-03-09
Model NumberR7D282CT
Catalog NumberR7D282CT
Lot Number30336973M
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOSENSE WEBSTER INC
Manufacturer Address33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2020-03-09

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