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

Catalog Number D134805

Device Problems Device Emits Odor (1425); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 04/03/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced coronary sinus perforation that required pericardiocentesis.It was reported that just prior to the first radio frequency (rf) delivery, multiple errors appeared on the carto 3 system, related to the ngen generator stating: "electrode temperature fault" (code unknown), 279: "rf cable disconnected," and 273: "catheter status warning." to troubleshoot the catheter cable was exchanged, the staff ensured indifferent electrodes were connected securely, without resolution.No further troubleshooting was performed for this issue because of a patient issue that was occurring.The patient suffered a coronary sinus perforation, which caused a pericardial effusion.After mapping the right and left ventricles for pvc's with the thermocool® smart touch® sf bi-directional navigation catheter, the physician was attempting to place the thermocool® smart touch® sf bi-directional navigation catheter into the coronary sinus (the caller stated the physician believed the perforation occurred while "poking around" in the coronary sinus).When they attempted to deliver rf energy, they were unable to due to the errors on the ngen (see aforementioned issue).The physician removed the thermocool® smart touch® sf bi-directional navigation catheter and discovered on the intracardiac echo (ice, soundstar catheter), the pericardial effusion.The pvc mapping procedure was stopped.The physician monitored the effusion for ten to fifteen minutes before a pericardiocentesis was performed.The patient was stable and interactive, lightly sedated, during the intervention.Last known patient status was stable.No ablations were performed during the procedure, only mapping with the thermocool® smart touch® sf bi-directional navigation catheter.The physician also reported after the procedure a "burning smell," believing the "electrode had a shortage." they did not indicate at what point in the procedure this occurred.Additional information was received.The physician¿s opinion on the cause of this adverse event, the physician took responsibility for the effusion.The physician smelled a burning smell on the thermocool® smart touch® sf bi-directional navigation catheter.Just the smell was reported.No smoke reported.Was not worried about the patient condition after the pericardiocentesis.Patient was feeling okay (just a little chest pain) when leaving the room.Transseptal puncture was performed with a brk needle.The system error¿s / system warnings was assessed as not mdr reportable.The potential risk was low.The burning smell issue was assessed as a mdr reportable malfunction.The adverse event was assessed as a mdr reportable serious 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 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

The bwi product analysis lab received the device for evaluation 03-may-2024.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).

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19195775
• MDR Text Key: 341241069
• Report Number: 2029046-2024-01381
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• 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: 05/14/2024

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 Catalogue Number: D134805
• Device Lot Number: 31248308L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2024
• 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: BRK TRANSSEPTAL NEEDLE.; NGEN RF GENERATOR, US.; UNK CATHETER CABLE.; UNK_CARTO 3.; UNK_NGEN PUMP.; UNK_SOUNDSTAR ECO.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male