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

Model Number D138501

Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); Vasoconstriction (2126); Ischemic Heart Disease (2493)

Event Date 04/08/2022

Event Type  Injury  

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 reference number: (b)(4).

Event Description

It was reported that a (b)(6) male patient ( 182 cm, (b)(6)) underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.The patient suffered an air embolism that caused st elevation which required the patient undergo a coronary angiography.After insertion of the vizigo into the left atrium (la), after placement of stsf, st-segment elevation was observed in the inferior leads (ii, iii, avf) of the surface electrocardiogram, and blood pressure decreased.Air contamination was suspected.When the valve of the vizigo was checked, the valve (orange parts) had detached and remained on the dilator that had already been removed.This occurred about 5 to 10 minutes after insertion of the vizigo into the patient¿s body.The vizigo was removed, and cardiac catheterization was performed.There was spasm only in the right coronary artery.St elevation was decreased over time and vital signs were stabilized.Therefore, new vizigo was used, and the procedure was continued without any problem until the end of the procedure.The patient's vitals were also unchanged.Part of hemostatic valve (orange part) detached from the sheath while still attached to the dilator.Due to the detachment of the hemostatic valve component, air was mixed in the la, and st segment elevation and blood pressure decrease were noted on the surface electrocardiogram.Air embolism of right coronary artery occurred.At the time of air embolism, blood pressure decreased, and the patient was sweating profusely, st decreased with time and the symptoms was improved.There were no abnormalities in the surface electrocardiogram during or after the procedure, and the patient was able to communicate.The physician commented that ¿after the procedure, it was verified with the second vizigo, which had no problem, whether the drop of the hemostatic valve was due to the operation or not.The hemostatic valve was pulled strongly and put the dilator to apply torque, but there was no sign that it would come off.Therefore, suspected that the adhesive was not attached¿.The physician¿s opinion on the cause of this adverse event is that it was caused by bwi product malfunction.Medical intervention provided was coronary angiography; spasm observed at right coronary artery only.Over time, the st recovered, and the vitals stabilized without any intervention.The patient outcome of the adverse event is improved.The hemostasis valve (gasket) did not break into two or more separate pieces.This issue did not require percutaneous or surgical removal.Blood return was observed.The patient has not exhibited any neurological symptoms since the procedure was completed.Brim cap detachment is mdr-reportable.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.

Manufacturer Narrative

On 7-may-2022, the bwi product analysis lab received the device for evaluation.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.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 reference number: (b)(4).

Manufacturer Narrative

On 7-jul-2022, the product investigation was completed.It was reported that a 55-year-old male patient ( 182 cm, 89 kgs) underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.The patient suffered an air embolism that caused st elevation which required the patient undergo a coronary angiography.Device evaluation details: the device was inspected, and the hemostatic valve, the silicon ring, and the brim cap were not returned.A microscopic examination was performed, and evidence of adhesive marks was observed on the hub, meaning that the device was properly assembled.However, it is not possible to determine if the amount of adhesive was adequate for the union since the brim cap was not returned.Per the event, several tests were performed.The magnetic, features were tested, and no issues were observed.In addition, the product was deflecting correctly.The irrigation test could not be performed due to the missing brim cap and hemostatic valve.An electrical test was performed in accordance with bwi procedures.The catheter passed the electrical values within specification.At this time is not possible to determine the root cause of this condition, however, based on the information provided, the condition reported has its origin in someplace external to the manufacturing environment.All units are inspected prior to leaving the facility to avoid this type of damage.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.A device history record review was performed for the finished device 00001867 number, and no internal actions related to the complaint were found during the review.It should be noted that product failure is multifactorial.Based on the information currently available, microscopic examination of the returned product indicates that the hub has glue residues, and this shows that the brim cap was attached to the device.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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 ; 6465917981
• MDR Report Key: 14275569
• MDR Text Key: 291837800
• Report Number: 2029046-2022-00934
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/07/2022; 07/07/2022
• Supplement Dates FDA Received: 05/30/2022; 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 89 KG