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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); ST Segment Elevation (2059); No Code Available (3191)
Event Date 06/17/2020
Event Type  Injury  
Manufacturer Narrative
"since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed. Mre review: a manufacturing record evaluation was performed for the finished device 00001235 number, and no non-conformances related to the complaint was found during the review. (b)(4). If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a male patient underwent atrial fibrillation (afib) ablation procedure with carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium and suffered air embolism and st-segment elevations requiring coronary angiography. It was reported that during afib case the patient received an air embolism through the vizigo sheath which was followed by a blood pressure drop and st-segment elevation. A coronary angiogram was performed and no air embolism was observed in the coronary arteries. The st elevation and blood pressure returned to normal. 100% oxygen was given. The procedure was subsequently completed. The patient will be returned to coronary care unit (ccu) for observation. The event occurred during use of biosense webster product. In the opinion of the physician the cause of the patient event was procedure and staff error. The patient had fully recovered after 1 extra day of observation for any residual/neurological side effects. The sheath was not connected to the smartablate pump.
 
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Brand NameCARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC
33 technology drive
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER INC (IRVINE)
33 technology drive
irivine CA 92618
Manufacturer Contact
gabriel alfageme
31 technology drive
irvine, CA 92618
949789-868
MDR Report Key10260923
MDR Text Key199266335
Report Number2029046-2020-00846
Device Sequence Number1
Product Code DYB
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,Followup
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/08/2020
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number00001235
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/09/2019
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: 07/10/2020 Patient Sequence Number: 1
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