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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 Problems Material Separation (1562); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
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. (b)(4).
 
Event Description
It was reported that during an atrial fibrillation (afib) ablation procedure, while advancing the dilator through the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium, the white hemostatic valve of the hub became broken and appeared to get detached. The sheath could not be flushed. The sheath was replaced, and the issue resolved. The issue occurred prior to sheath usage on patient. Case was continued. It was also reported that the carto 3 system displayed error 6101 (no ethernet communication is detected) and 6150 (magnetic sensor error) when the soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter was connected to the front of the piu. The cable was exchanged, and the issue persisted. The catheter was exchanged, and the issue was resolved. No patient consequences were reported. The ultrasound recognition issue is not mdr-reportable. The hemostatic valve separation is mdr-reportable.
 
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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 Key11099888
MDR Text Key224532154
Report Number2029046-2020-02033
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 01/13/2021
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? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/08/2021
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number00001479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2020
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
CARTO 3 SYSTEM.; SOUNDSTAR ECO.; VIZIGO SHEATH.
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