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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 ¿ SMALL INTRODUCER, CATHETER

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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER Back to Search Results
Model Number D138501
Device Problem Backflow (1064)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2021
Event Type  malfunction  
Event Description
It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ small and air was suspected to be inside the sheath. After mapping with using the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ small it was suspected there was an air inside the sheath. According to the vizigo guide, air entered the sheath when the catheter was removed after mapping. Thereafter, the patient was followed up without any changes in vital signs. There were no changes in the patient's condition. The patient was followed-up. The physician commented that the possibility that the sheath was in the ra and the tip was touching the wall. A small amount of air was confirmed in the sheath, but it was unknown whether it entered the heart. There was concern that it may have been introduced into the body by the air in the sheath. The physician performed maneuvers to eliminate bubbles. No medical intervention was required because no patient consequence occurred. The patient has not exhibited any neurological symptoms since the procedure was completed. They did not think it was a product defect. The product itself was not replaced and was used as is.
 
Manufacturer Narrative
Initial reporter phone: (b)(6). If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's ref. # (b)(4).
 
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Brand NameCARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL
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 Key13116142
MDR Text Key287583840
Report Number2029046-2021-02275
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016253
UDI-Public10846835016253
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/08/2022
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00001779
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2021
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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