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

Model Number D128211

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

Patient Problems Cardiac Arrest (1762); Ischemic Heart Disease (2493)

Event Date 05/13/2022

Event Type  Death  

Manufacturer Narrative

Device investigation details: 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.A device history record evaluation was performed for the finished device 30736880l number, and no internal action related to the complaint was found during the review.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 ref.# (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient ((b)(6)) underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and the patient suffered st elevations, cardiac arrest and eventually died after 60 minutes of cardiopulmonary resuscitation (cpr) and a coronary angiography and an attempted stent placement.A patient with serious cardiac history (3 coronary bypass) was scheduled for pulmonary vein isolation (pvi)/ and atrial fibrillation (afib) ablation.Patient presented in afib, normal femoral access was used for a cs + right ventricular apical (rva) catheter and a steerable sheath (agilis from st jude medical).Transseptal puncture was fine.When advancing the pentaray nav high-density mapping eco catheter into the left atrium approx.30s after there were minor st elevations visible on body surface (bs) electrocardiogram (ecg).St elevations didn¿t change, blood pressure was fine.After 2-3 minutes patient had atrioventricular (av) nodal block / ventricular asystole.Using rva pacing we could remain on good blood pressure.Approximately 5 minutes later, blood pressure dropped into 40 mmhg and we started cpr.Additional staff came on site for intubation and emergency coverage.During coronary angiography under constant cpr there was found no air embolism in the coronaries.Mild-middle grade narrowing in the remaining bypasses were observed.Dilatation and attempt of stenting were non-successfully and patient was declared dead after 60min of cpr on the operating (or) table.The surgery was delayed 100 minutes.The procedure was not successfully completed.The physician¿s opinion, on the cause of death was unclear.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14652978
• MDR Text Key: 293691843
• Report Number: 2029046-2022-01257
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30736880L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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: SMARTABLATE GENERATOR KIT-WW; STEERABLE SHEATH (AGILIS FROM ST JUDE MEDICAL); UNKNOWN CS CATHETER; UNKNOWN RIGHT VENTRICULAR APICAL (RVA) CATHETER
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 86 KG