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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 - LARGE INTRODUCER, CATHETER

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BIOSENSE WEBSTER INC CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE INTRODUCER, CATHETER Back to Search Results
Model Number D138503
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
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. Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a patient underwent cardiac ablation procedure for left non-ischemic ventricular tachycardia with a carto vizigo¿ 8. 5f bi-directional guiding sheath - large where hemostatic valve detachment occurred. It was reported that the hemostatic valve and the brim cap detached from the carto vizigo¿ 8. 5f bi-directional guiding sheath - large detached when the healthcare professional was flushing the sheath. The sheath was not introduced into the patient's body. No air entered the patient, and no patient consequences were reported. The sheath was replaced and the procedure was continued. It was also reported that the carto 3 system was cycling 1-2-3 through the initialization phase. To troubleshoot the carto 3 system was rebooted several times. Around the 3rd time of the reboot, the carto 3 system displayed "location pad current leak". The caller turned off the patient interface unit and exchanged the location pad extension cable. The patient interface unit was rebooted, and the initialization was completed. ' the location pad issue is not mdr-reportable. The start-up error is not mdr-reportable. The hemostatic valve detachment is mdr-reportable.
 
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Brand NameCARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE
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 Key11101668
MDR Text Key229527153
Report Number2029046-2020-02039
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016260
UDI-Public10846835016260
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 12/09/2020
1 Device was Involved in the Event
0 Patients were 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 Date01/23/2021
Device Model NumberD138503
Device Catalogue NumberD138503
Device Lot Number00001085
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 Manufactured01/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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