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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER

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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER Back to Search Results
Model Number D138502
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Cardiac Tamponade (2226)
Event Date 05/17/2022
Event Type  Injury  
Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed. Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident. Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a (b)(6) male patient ((b)(6)kg) underwent an atrial fibrillation (afib) with a carto vizigo¿ 8. 5f bi-directional guiding sheath medium and a thermocool® smart touch® sf uni-directional navigation catheter. The patient suffered cardiac tamponade requiring pericardiocentesis and prolonged hospitalization. The patient suffered a cardiac tamponade, the blood pressure dropped suddenly while ablating in the left atrium and the effusion was on the right side. The effusion was confirmed with an intracardiac echocardiogram. A pericardiocentesis was performed and 550 cc of fluid was removed and "some of that" was transfused back into the patient. At the time of the call the patient was intubated but stable and being admitted for overnight observation. The physician indicated it may have been the carto vizigo¿ 8. 5f bi-directional guiding sheath medium that created the complication, but that he was not sure as of the time of the call. Additional information was received on the event. The patient required further hospitalization. Physician wanted to rerun bloodwork and confirm levels were okay before extubating. The physician believes it may have been caused by a carto vizigo¿ 8. 5f bi-directional guiding sheath - medium left in the right atrium that was not being actively used. The last update was the patient was still intubated but all blood work came back normal. Transseptal puncture was performed with a st. Jude brk-1 98cm needle. There was no evidence of a steam pop. An irrigated catheter was used in the event and the flow setting were set at standard smart touch sf settings. The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation. No error messages observed on biosense webster equipment during the procedure. Force visualization features used were graph, dashboard, vector and visitag with standard settings and no additional filter used with the visitag and the color options used prospectively were surpoint. There was no ablation on the right side. Intubation was done at the start of the procedure and maintained through recovery. Based on the available information, this event was assessed as mdr reportable for both the carto vizigo¿ 8. 5f bi-directional guiding sheath medium and the thermocool® smart touch® sf uni-directional navigation catheter. The physician believes it may have been caused by a carto vizigo¿ 8. 5f bi-directional guiding sheath medium left in the right atrium. Ablation was performed.
 
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Brand NameCARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER INC (IRVINE)
33 technology drive
irvine CA 92618
Manufacturer Contact
michelleann garcia
31 technology dr
irvine, CA 92618
646591-798
MDR Report Key14640997
MDR Text Key293625875
Report Number2029046-2022-01244
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016277
UDI-Public10846835016277
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD138502
Device Catalogue NumberD138502
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2022 Patient Sequence Number: 1
Treatment
BWI-DECANAV CATHETER.; GENERIC - PENTARAY.; NON BWI-ST. JUDE BRK-1 98CM NEEDLE.; SMARTABLATE GENERATOR KIT-US.; THMCL SMTCH SF UNID, TC, F.; UNK_CARTO 3.; UNK_ESOPHASTAR.
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