MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number NI75TCDH

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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).

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation with a navi-star¿ thermo-cool¿ electrophysiology catheter and the patient experienced cardiac perforation that required surgical intervention and prolonged hospitalization.It was reported that pericardial tamponade was noticed after ablation.Blood was drained and given back to patient.The physician's assessment was that the tamponade happened during transseptal puncture (tsp).Patient experienced blood loss and pain.The patient was moved to the "chest pain unit" after procedure.Additional update from the hospital was received on (b)(6) 2024 morning.The patient required open heart surgery after the procedure.The puncture/tamponade was in the left ventricular (lv) apex.The head of electrophysiology assumes this is due to the use of a non-contact force catheter and has asked the operator to use contact force catheters in the future.The physician's opinion on the cause of this adverse event was that it was procedure related.A fairly large amount of mapping and ablation were performed with a non-contact force sensing catheter.Patient has improved.Patient required extended hospitalization as the patient required open heart surgery to stabilize and had to stay for recovery.No steam pop was noted.No error messages observed on biosense webster inc.(bwi) equipment during the procedure.Location of the perforation was in the lv apex.Cardiac perforation was confirmed.

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 18611825
• MDR Text Key: 334140208
• Report Number: 2029046-2024-00354
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: 10846835000559
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NI75TCDH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ABBOTT BRK NEEDLE; NGEN RF GENERATOR; UNK PUMP; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male