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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 12/03/2020
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. Investigation is in progress, once completed a supplemental will be submitted. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Initial reporter phone: (b)(6). Manufacturer's ref. # (b)(4).
 
Event Description
It was reported that a patient underwent cardiac ablation procedure with carto vizigo¿ 8. 5f bi-directional guiding sheath - medium and suffered cardiac tamponade requiring no intervention. During the transseptal puncture with carto vizigo¿ 8. 5f bi-directional guiding sheath - medium and brk-1 needle (abbott) a sudden drop in blood pressure was observed and a tamponade was diagnosed. The patient stabilized very quickly and no pericardial puncture was needed. The procedure was stopped at the stage and the patient was kept in the hospital for further observation. No ablation catheter has been used yet as the incident happened during transseptal. There were no error messages on biosense webster equipment. The physician¿s opinion is that the event was procedure-related. The patient had fully recovered. It is unknown whether extended hospitalization was required. The event is conservatively recorded under the vizigo sheath.
 
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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 dr
irvine, CA 92618
9497898687
MDR Report Key11101731
MDR Text Key224589010
Report Number2029046-2020-02038
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016277
UDI-Public10846835016277
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/14/2021
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number00001449
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/14/2020
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: 12/31/2020 Patient Sequence Number: 1
Treatment
BRK-1 NEEDLE (ABBOTT)
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