MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV ECO; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D124500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 09/30/2022

Event Type  Death  

Event Description

It was reported that an unknown male patient in his 50¿s underwent a ventricular tachycardia (vt) ablation procedure with a generic - pentaray.The patient suffered cardiac tamponade requiring pericardiocentesis, cpr, and ultimately death.An adverse event occurred in a patient undergoing a ventricular tachycardia ablation.Patient had both femoral venous and epicardial access.Right ventricle was punctured with needle and introducer wire was inserted into the ventricle.Wire retracted into the pericardium and sheath inserted.Patient bled into pericardium, blood pressure dropped, and cpr was commenced.At the time of cpr and decanav catheter was in the coronary sinus and a pentaray catheter in the pericardium.Blood was drained from the pericardium and patient stabilized.Procedure continued, epicardium was mapped, no ablation therapy delivered.Patient survived cardiac cath lab.There were patient consequences of blood loss and cpr.The adverse event occurred on (b)(6) 2022.This adverse event was discovered during use of biosense webster products, catheters were in the body.The physician¿s opinion on the cause of this adverse event is that it was due to procedure and patient condition.Intervention provided was cpr with pericardial tap/drainage.The patient outcome of the adverse event was death, patient survived the cath lab but later died in icu the same day.The patient's current status is deceased.Puncture was not actively repaired, pericardial drain remained insitu on leaving the cath lab.No ablation performed in this procedure, only mapping.A transseptal puncture was not performed.Prior to noting the cardiac tamponade, ablation was not performed, only mapping.The event occurred prior to these phases, event occurred during epicardial access.In physician¿s opinion, the cause of death was refractory cardiogenic shock/ ventricular arrhythmia.The patient survived the lab later dying in icu.The physician doesn¿t believe the incident attributed to cause of death.The pentaray did not perforate, it was in the pericardial space however when the patient tamponade occurred.This event will be coded under the pentaray as it was reported to be in the epicardial space at the time of the event.All deaths were bwi fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.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: PENTARAY NAV ECO
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 15675244
• MDR Text Key: 302439954
• Report Number: 2029046-2022-02649
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D124500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2022
• 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: DECANAV; UNK_SMART TOUCH BIDIRECTIONAL
• Patient Outcome(s): Life Threatening; Death; Required Intervention
• Patient Sex: Male