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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 Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2022
Event Type  malfunction  
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation issue occurred. It was reported that the hemostatic valve of the vizigo¿sheath became dislodged and there was blood leaking. The white gasket was inside the hub dislodged. The gasket looked to remain intact. The sheath was in the patient when the problem occurred. No air entered the patient. The issue did not require surgical intervention just a sheath exchange. No hemodynamic instability was observed. Blood loss was minimal. The sheath was exchanged, and the issue was resolved, and the case continued without any further incident. No adverse patient consequence was reported.
 
Manufacturer Narrative
The biosense webster, inc. Product analysis lab received the device for evaluation. The analysis has begun but is not completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. This report is being submitted pursuant to the provisions of 21 cfr, part 4. This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by biosense webster, inc. , or its employees that the report constitutes an admission that the product, biosense webster, inc. , or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Manufacturer's reference number: (b)(4).
 
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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 Key15312613
MDR Text Key302724188
Report Number2029046-2022-02023
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 09/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number50000171
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received09/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2022
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: 08/29/2022 Patient Sequence Number: 1
Treatment
UNK BRAND SHEATH
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