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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 Patient Device Interaction Problem (4001)
Patient Problem Cardiac Arrest (1762)
Event Date 05/10/2022
Event Type  Injury  
Event Description
It was reported that a (b)(6) male patient underwent an atrial flutter right (r-afl) ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath - small. The patient suffered cardiac arrest requiring cpr. It was reported that at the beginning of a right-sided atrial flutter procedure, asystole was noticed in the patient. After the patient was put under anesthesia, the anesthesiologist noticed that the patient's blood pressure dropped. The patient went into asystole, and "turned blue. " there were no r waves present on the recording system or the anesthesia monitor. The physician had access with the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ small at this point in the procedure, but no catheters had been introduced to the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ small. A code was called for the patient. The medical intervention provided was to resuscitate the patient, and cardiopulmonary resuscitation (cpr) was performed. The procedure was aborted. The patient was reported to be in stable condition, and the patient was transferred to the intensive care unit. The physician noticed prior to the procedure, when performing a transesophageal echocardiogram (tee), that the patient had an "enormous" right atrium. The physician believes the cause of the issue may be due to undiagnosed pulmonary hypertension. Additional information was received on the event. This adverse event was discovered during use of biosense webster products. The physician¿s opinion on the cause of this adverse event is that it was patient condition. The patient regained rhythm, stabilized, and was transferred to icu. The patient did require extended hospitalization as he was admitted to icu instead of having procedure and going home. A generator was not used.
 
Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed. A manufacturing record evaluation was performed for the finished device number 00001948 and no internal action related to the complaint was found during the review. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's reference number: (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
michelleann garcia
31 technology dr
irvine, CA 92618
646591-798
MDR Report Key14599411
MDR Text Key293335001
Report Number2029046-2022-01189
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016253
UDI-Public10846835016253
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
Report Date 06/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00001948
Was Device Available for Evaluation? No
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2022
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: 06/04/2022 Patient Sequence Number: 1
Treatment
UNKNOWN BRAND ANESTHESIA MONITOR; UNKNOWN BRAND RECORDING SYSTEM
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