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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 Problems Air Embolism (1697); Cardiac Arrest (1762)
Event Date 07/07/2022
Event Type  Injury  
Manufacturer Narrative
Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed. Investigation is in progress, once completed a supplemental will be submitted. This report is being submitted pursuant to the provisions of 21 cfr, part 4. This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by biosense webster inc. , or its employees that the report constitutes an admission that the product, biosense webster inc. , or its employees caused or contributed to the potential event described in this report. 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 ref. # (b)(4).
 
Event Description
It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath - small and the patient suffered air embolism and cardiac arrest requiring cardiopulmonary resuscitation (cpr), surgical intervention and prolonged hospitalization. It was reported that after an afib case as they were removing the carto vizigo¿ 8. 5f bi-directional guiding sheath - small, air entered the patient¿s aorta via the flush line that was connected to the sheath in the left atrium. The patient displayed symptoms of bradycardia and no pulse. The emboli were confirmed with an x-ray. The medical intervention provided was brief cpr, pacing, and removal of the air through a pigtail catheter. The patient was reported to be in stable condition. The caller reported that critical care recommended leaving him intubated overnight. The physician believed the issue to have occurred due to a brief myocardial infarction (mi) from air in the coronary and that they are hoping to prevent a cerebrovascular accident (cva). This adverse event was discovered immediately after isolating the pulmonary veins. The physician¿s opinion on the cause of this adverse event is that it was the procedure. Flush bag to sheath was on a pressure bag. The bag went dry, and air was introduced into left atrium (la). Intervention provided was cpr, pacing, removal of air via a pigtail catheter, and ventilation. The patient outcome of the adverse event is improved. The patient did require extended hospitalization because of the adverse event as treatment for air emboli is 100% oxygen and ventilation. Patient was removed from vent the following day with no deficits. Additional information was received indicating the air that entered the patient came from a 1000cc bag that was on a pressure bag connected to iv drip tubing; no pump involved. Hospital analyses of the incident concluded that bad roller clamp on iv tubing allowed saline bag to empty prematurely. Air did not enter through smart touch catheter, thus no alarm nor any error codes occurred.
 
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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 Key15161829
MDR Text Key297211107
Report Number2029046-2022-01784
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00002004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2022
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: 08/04/2022 Patient Sequence Number: 1
Treatment
SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; THMCL SMTCH SF BID, TC, D-F
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