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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); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2022
Event Type  malfunction  
Manufacturer Narrative
The product has not returned for analysis, however, a picture(s) were provided by the customer. Evaluation is still in progress. 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. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's ref. # (b)(4).
 
Event Description
It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium and a hemostatic valve detachment occurred. It was reported there was a defect on the diaphragm at the dilator insertion part. The white ring /gasket was inside the vizigo handle. The hemostatic valve looked deformed. There was resistance when they were trying to put the catheter into the sheath. There was no occlusion when irrigating the sheath, however, the sheath was completely blocked since the catheter was not still able to be moved through the sheath. They were inserting the dilator into the sheath. This was identified before the case. The sheath was not being used on the patient; the issue was recognized before being used. Air did not enter the patient¿s body. This issue did not require percutaneous or surgical removal. Blood return was not observed. There were no wires being exposed or any lifted or sharp rings. The sheath was replaced and the issue resolved. The carto 3 system is operating per specs and is not responsible for the product issue.
 
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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
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key13936049
MDR Text Key290455129
Report Number2029046-2022-00662
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 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/05/2022
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number00001875
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2021
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: 03/29/2022 Patient Sequence Number: 1
Treatment
8.5F SHEATH WITH CURVE VIZ MDC; CARTO 3 SYSTEM
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