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); Ventricular Tachycardia (2132); Pericardial Effusion (3271)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

The biosense webster product analysis lab received the device for evaluation.Upon initial inspection, no visual damage or anomalies observed.The 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.Manufacture reference no: (b)(4).

Event Description

It was reported that a (b)(6) year old female patient with history of kidney failure and constant dialysis, underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a pentaray nav high-density mapping eco catheter and suffered ventricular fibrillation (vfib) and cardiac arrest requiring cardioversion, cardiopulmonary resuscitation (cpr) and extracorporeal membrane oxygenation (ecmo).Prior to mapping, as soon as the soundstar catheter was introduced, a large baseline pericardial effusion was noted around the patient¿s right and left ventricles.The vt voltage mapping procedure was continued, as the patient was in stable condition.While carto 3 mapping in the left ventricle (lv) around the mitral valve with the pentaray catheter, the patient went into incessant vfib.Multiple cardioversions were delivered, and cpr was performed; however, the patient remained in vfib for over an hour and a half.The patient was then put on ecmo.Mapping continued as the patient recovered and was stable.The patient was in sinus rhythm and stable at the end of the mapping procedure.Extended hospitalization was required as a result of the event, the patient still on ecmo and was scheduled for another procedure on 3/9/2020.Physician¿s opinion regarding the cause of the event is that it was patient condition and procedure related.Transseptal puncture was performed during the procedure with a safe sept needle.An stsf ablation catheter was opened and inserted into the body briefly but was not in the body during vfib.No ablations were delivered throughout the case.The catheter irrigation was set within normal settings for stsf, only at 2 ml/min since no ablation performed.This event will be conservatively reported under the pentaray catheter as it cannot be excluded that the pentaray did not result in ventricular ectopy which could have initiated vf though it is very likely that patient condition was the main contributing factor.

Manufacturer Narrative

It was reported that a 45-year-old female patient with history of kidney failure and constant dialysis, underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a pentaray nav high-density mapping eco catheter and suffered ventricular fibrillation (vfib) and cardiac arrest requiring cardioversion, cardiopulmonary resuscitation (cpr) and extracorporeal membrane oxygenation (ecmo).The investigational analysis completed (b)(6)2020.The device was visually inspected, and it was found in good conditions.The magnetic and electrical features were tested, and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed and no internal actions were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use state that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacture reference no: (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9896110
• MDR Text Key: 191694463
• Report Number: 2029046-2020-00497
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30311177L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 04/01/2020
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SAFESEPT TRANSSEPTAL NEEDLE; SOUNDSTAR ECO SMS 8F CATHETER; THCL SMTCH SF BID TC, F-J, IDE
• Patient Age: 45 YR