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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 06/08/2022
Event Type  Injury  
Manufacturer Narrative
Additional information received indicates that the device is not available for return, 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. Manufacturer's reference number: pc-(b)(4).
 
Event Description
It was reported that a 69-year-old male patient underwent an atrial flutter left (l-afl) ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath-medium. The patient suffered cardiac tamponade requiring a pericardiocentesis. The patient suffered a pericardial effusion during the transseptal. On fluoroscopy, it appeared as if the wire was wrapping around the heart shadow. Ablation catheter was not in the body at this time. After the transseptal, the pressure dropped. Anesthesia treated the pressure and echo was called and a tee was performed which confirmed fluid in the pericardium. Physician decided to proceed with the case. Once the mapping and ablation were completed, interventional radiology (ir) was called, a pericardiocentesis was performed and fluid was removed from the pericardial space. The patient was stable once pericardiocentesis was performed. Additional information was received on the event. The physician¿s opinion on the cause of this adverse event was that it was procedure related. A cardiologist was called, and the patient was drained. The patient outcome of the adverse event was fully recovered (no residual effects). There is no information about the hospitalization. Prior to noting the cardiac tamponade, ablation was not performed. There was no evidence of a steam pop. The event occurred during transseptal puncture. The irrigated catheter was used in the event and the flow setting was typical settings for the st catheter. The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation. No error messages were observed on biosense webster equipment during the procedure. Force visualization features used were graph, dashboard, vector & visitag with the visitag module parameters for stability max distance change: 2mm, min time: 5s, 50% over 4g with impedance drop.
 
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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 Key14881416
MDR Text Key295124336
Report Number2029046-2022-01491
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,Followup
Report Date 07/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
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 Received07/06/2022
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: 06/30/2022 Patient Sequence Number: 1
Treatment
GENERIC - PENTARAY; SMARTABLATE GENERATOR KIT-US; UNKNOWN BRAND DEFLECTABLE QUAD CATHETER; UNKNOWN BRAND PUMP; UNK_CARTO 3; UNK_SMART TOUCH BIDIRECTIONAL SF
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