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 Arrhythmia (1721)

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).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.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 an av node ablation with a navi-star¿ thermo-cool¿ electrophysiology catheter and the patient experienced arrhythmia from ablation catheter displacing the right ventricle (rv) electrode.This required rv electrode re-adjustment.Preceding the av node ablation, the patient underwent a pacemaker revision for a displaced rv electrode.Following the successful revision, an av node ablation was performed.During the handling of the ablation catheter in the right atrium, the rv electrode was touched and displaced by the ablation catheter.Following the displacement, pacing at 1300 ms was performed from rv with a quadrapolar catheter.The av node ablation was successfully performed.During the preparation for the re-adjustment of the rv electrode, the ep recording system was reset and the pacing from rv catheter was unintentionally interrupted by the nursing personal for about one minute.During this time, the patient showed a very slow escape rhythm.After that the pacing was restored and the rv electrode was re-adjusted in place for a correct pacing.It's the physician's opinion that the complication was not caused by a johnson & johnson product.Additional information was received.The asystole happened during use of fix 6f,4p,a,sd,5mm,12pn eeprom/f6qa005ct and carto3 external refpatch 6pack/crefp6.The physician's opinion is that the adverse event was not caused by a malfunction of a biosense webster, inc.Product, but because the software responsible for pacing was closed by the nursing team, so the cause must be identified as procedure.Patient improved in the short term but with unknown in the long term effects.The pacemaker was re-adjusted via a separate access, different from the one used for the ablation.

• 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: 18842018
• MDR Text Key: 336958464
• Report Number: 2029046-2024-00737
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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: 02/08/2024
• 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: CARTO3 EXTERNAL REFPATCH 6PACK; FIX 6F,4P,A,SD,5MM,12PN EEPROM; NGEN GENERATOR; UNK EP RECORDING SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female