MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER

Model Number D138502

Device Problems Backflow (1064); Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762)

Event Date 08/04/2022

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a male patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.There was air in the sheath and the patient suffered an air embolism which caused ventricular fibrillation (cardiac arrest) requiring defibrillation.Air in the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was observed by the examiner.The map catheter system (smart touch sf).While smart touch sf was inserted in the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium before ablation.Ventricular fibrillation developed as a result of air embolism.Continuous sheath-irrigation was done during entire procedure.The patient was in normal sinus rhythm at the end of procedure.The procedure was successfully completed.Additional information was received.The physician removed the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and the smart touch sf from the patient and flushing/ irrigation the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, pentaray and smart touch sf again.The ventricular fibrillation required defibrillation.The patient has not exhibited any neurological symptoms since the procedure was completed.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was a biosense webster, inc.Product malfunction.The patient outcome of the adverse event was fully recovered (no residual effects).It is unknown if the patient required extended hospitalization because of the adverse event.The smart touch sf catheter did not have a sensor error.There was no malfunction reported on either the generator or the pump.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.The air in the sheath was assessed as a mdr reportable malfunction.The potential for air embolism as the air in the side port tubing has the potential to mobilize resulting in an increased risk to the patient.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 13-sep-2022.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 reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 01-oct-2022.It was reported that a male patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.There was air in the sheath and the patient suffered an air embolism which caused ventricular fibrillation (cardiac arrest) requiring defibrillation.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed that no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A device history record was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(6)the product investigation was reopened to clarify/correct the investigation findings which resulted in the following changes/corrections.The clarification/corrections were completed on 05-nov-2022.It was reported that a male patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.There was air in the sheath and the patient suffered an air embolism which caused ventricular fibrillation (cardiac arrest) requiring defibrillation.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed that no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A device history record was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states the warnings, from the sideport only, aspirate all air prior to fluid infusion.Before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate.After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli.Flush and maintain continuous saline.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
• Type of Device: INTRODUCER, 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 Key: 15308438
• MDR Text Key: 298773181
• Report Number: 2029046-2022-02011
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW; THMCL SMTCH SF UNID, TC, F
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male