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

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.

Manufacturer Narrative

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).Device investigation details: the device investigation has been completed which included performing a manufacturing record evaluation (mre).A manufacturing record evaluation was performed for the finished device number 00002004 and no internal actions related to the complaint was found during the review.Still no device has been received for analysis, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Based on the completed mre, the h4.Device manufacture date has been populated with 22-may-2022.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL
• 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: 15161829
• MDR Text Key: 297211107
• Report Number: 2029046-2022-01784
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• 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 Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00002004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2022
• 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: SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male