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

Catalog Number D132705

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 07/13/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent atrioventricular reentrant tachycardia (avrt)/(wpw) ablation procedure that included thermocool® smart touch¿ bi-directional navigation catheter.The patient experienced heart block that required medical and surgical intervention.It was reported that a heart block occurred during the procedure.They were burning anterior to the coronary sinus and after 51 seconds of ablation, a spike in impedance was displayed on the carto 3 system and the smartablate remote.The physician heard a steam pop and came off ablation.The patient went into a heart block right after the steam pop.The heart block was confirmed with the intracardiac signals displayed on the carto 3 system.The atrial signals did not line up with the ventricular signals.The patient was given isuprel and steroids.The heart block continued thirty minutes later.A temporary wire was put into the patient to pace the patient's heart.The patient will be held overnight and if the rhythm does not come back, a pacemaker will be put into the patient in the morning.The patient was reported to be in stable condition.The physician believed that the heart block occurred due to the steam pop.Additional information was received.Generator parameters and thresholds: power control, 50w.Temperature and impedance unknown, 50w for power.Length of ablation cycle when the pop was observed at the same tip position: 51 seconds.Errors reported by the biosense webster systems was an impedance spike cut off.Patient required extended hospitalization, 3 day observation with steroids and isuprel.Since the event was 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 was to be considered serious.The steam pop was assessed as non mdr reportable.Steam pop is not considered to be a device malfunction.Steam pop was an expected physiological phenomenon.

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.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 803.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).

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)(4) during an internal review on 10-aug-2023, noted a correction to the 3500a initial under h10.Additional manufacturer narrative.Initially reported: 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.Should have reported: 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.A manufacturing record evaluation was performed for the finished device 31051050m number, and no internal action related to the complaint was found during the review.H6.Type of investigation should have included: analysis of production records (b14).H6.Investigation findings was processed as results pending completion of investigation (c21) and should have been no findings available (c20).H6.Investigation conclusions was processed as conclusion not yet available (d16) and should have been cause not established (d15).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17504598
• MDR Text Key: 320863816
• Report Number: 2029046-2023-01754
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

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 Catalogue Number: D132705
• Device Lot Number: 31051050M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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-WW; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 50 KG