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

Model Number NI75TCDH

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).

Event Description

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.Map of right ventricle (rv) and left ventricle (lv) was done with pentaray catheter.Then they started ablation with navi-star¿ thermo-cool¿ electrophysiology catheter in the rv.The ablations were close to the implantable cardioverter defibrilators (icd) lead in the rv.After six ablation points, physician did an ultrasound and an epicardial effusion is noticed.A pericardiocentesis was performed.When the hemodynamics of the patient were stable again, physician continue the ablation phase in the lv.Vt was not inducible anymore, and the procedure was finished.Patient was stable at the end of the case.

Manufacturer Narrative

On 1-sep-2022, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.Map of right ventricle (rv) and left ventricle (lv) was done with pentaray catheter.Then they started ablation with navi-star¿ thermo-cool¿ electrophysiology catheter in the rv.The ablations were close to the implantable cardioverter defibrillators (icd) lead in the rv.After six ablation points, physician did an ultrasound and an epicardial effusion is noticed.A pericardiocentesis was performed.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, temperature features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The ifu (instruction for use) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15324615
• MDR Text Key: 298949058
• Report Number: 2029046-2022-02041
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NI75TCDH
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 30839799M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2022
• 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: PENTARAY NAV ECO 7FR, F, 2-6-2
• Patient Outcome(s): Required Intervention; Life Threatening