MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Respiratory Failure (2484)

Event Date 11/26/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(4).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 (b)(4) number, 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).

Event Description

It was reported that a (b)(6) male patient underwent an right pulmonary vein isolation (rpvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac arrest and respiratory failure requiring cardiac massage and intervention.It was reported that when ravonal was administered more than usual at the physician's discretion to suppress respiratory disturbance, respiratory arrest and cardiac arrest occurred.Cardiac massage was performed with immediate backup of ventricular pacing.After that, the heartbeat resumed "in a few 10 seconds" but blood pressure was low, so noradrenaline and adrenaline were administered, and blood pressure returned to normal in 12 to 13 minutes.This event occurred after right pulmonary vein isolation (rpvi) was ended.The event resolved with cardiac massage and medication (noradrenaline, adrenaline).After the procedure, sedation was effective, but there were no problems with heart rate and blood pressure.Respiratory arrest, cardiac arrest.Clinical course is under investigation.The physician commented that the event is not related to the products used.The medical staff has therefore reported this event as a case of respiratory and cardiac arrest due to over-sedation during carto3 use.On (b)(6) 2021, bwi received information indicating that the patient was unconscious, and it may be difficult for the patient to return to society.On (b)(6) 2021, bwi received further information regarding the event.This adverse event occurred on (b)(6) 2021.This adverse event was discovered during use of biosense webster products.After providing cardiac massage and medication (noradrenaline, adrenaline), the patient's blood pressure and heart rate returned to the normal level but the patient remained unconscious.The patient outcome of the adverse event is unchanged.The patient is still unconscious and hospitalized.Since it is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Event Description

It was reported that a (b)(6) male patient underwent an right pulmonary vein isolation (rpvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac arrest and respiratory failure requiring cardiac massage and intervention.It was reported that when ravonal was administered more than usual at the physician's discretion to suppress respiratory disturbance, respiratory arrest and cardiac arrest occurred.Cardiac massage was performed with immediate backup of ventricular pacing.After that, the heartbeat resumed "in a few 10 seconds", but blood pressure was low, so noradrenaline and adrenaline were administered, and blood pressure returned to normal in 12 to 13 minutes.This event occurred after right pulmonary vein isolation (rpvi) was ended.The event resolved with cardiac massage and medication (noradrenaline, adrenaline).After the procedure, sedation was effective, but there were no problems with heart rate and blood pressure.Respiratory arrest, cardiac arrest.Clinical course is under investigation.The physician commented that the event is not related to the products used.The medical staff has therefore reported this event as a case of respiratory and cardiac arrest due to over-sedation during carto3 use.On 29-nov-2021, bwi received information indicating that the patient was unconscious, and it may be difficult for the patient to return to society.On 14-dec-2021, bwi received further information regarding the event.This adverse event occurred on (b)(6) 2021.This adverse event was discovered during use of biosense webster products.After providing cardiac massage and medication (noradrenaline, adrenaline), the patient's blood pressure and heart rate returned to the normal level but the patient remained unconscious.The patient outcome of the adverse event is unchanged.The patient is still unconscious and hospitalized.Since it is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

(b)(6).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 30604424l number, 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.(b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13029429
• MDR Text Key: 286144625
• Report Number: 2029046-2021-02213
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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
• Report Date: 12/17/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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
• Treatment: CARTO 3 SYSTEM.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male