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

Model Number D128208

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

Patient Problems Thrombosis (2100); Cardiac Tamponade (2226)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The event date is unknown.As a result, the 1st day of the month of the alert date has been entered as the under date of event.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a female patient of around 70-80 years old with history of ischemic scar on anterior right and left ventricle and large aneurism on right anterior ventricle, underwent an ablation procedure on which a pentaray nav high-density mapping eco catheter was used and suffered cardiac tamponade (requiring pericardiocentesis and medication) and thrombosis.During the case, fluoroscopy guided epicardial access on the chest below the sternum was gained with a st.Jude agilis epi 8.5f device.Then, the pentaray nav high-density mapping eco catheter was introduced to the pericardium and used for mapping the left ventricle and right anterior ventricle.A sudden drop in patient¿s blood pressure occurred (110 systolic to 66 systolic) whilst mapping the very large scar and aneurism area of the right ventricle.Cardiac tamponade was then confirmed by ultrasound, and a pericardiocentesis was performed to remove 800ml of venous blood.Protamine medication was also administered.Patient¿s condition worsened and developed clotting in several veins.Extended hospitalization was required to treat the clotted veins, the treatment performed was not specified; however, it was confirmed that surgical intervention was not required.The patient was admitted into the intensive care unit (icu) and was reported in stable condition.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.Physician suspects the perforation of the thin walled scarred aneurism on the right anterior ventricle occurred during mapping with the pentaray nav high-density mapping eco catheter.The smarttouch sf catheter was connected to the carto 3 system; however it was not introduced into patient and was left lying on the patient¿s chest.No error messages were observed on any biosense webster, inc.Equipment.The irrigation for the pentaray nav high-density mapping eco catheter was set at 2ml/min.

Manufacturer Narrative

After further review on march 24, 2020, it was noted that there was reported off-label use of the pentaray¿nav eco high -density mapping catheter in the pericardial space per the indications for use: the biosense webster pentaray¿nav eco high-density mapping catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.E., recording or stimulation only.This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.The pentaray¿nav eco high density mapping catheter provides location information when used with compatible carto¿ 3 ep navigation systems.(this catheter is not compatible with carto¿ 3 ep navigation systems prior to version 3.X).The biosense webster, inc.Product analysis lab received the device for evaluation on april 3, 2020.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Investigation summary: it was reported that a female patient of around 70-80 years old with history of ischemic scar on anterior right and left ventricle and large aneurism on right anterior ventricle, underwent an ablation procedure on which a pentaray nav high-density mapping eco catheter was used and suffered cardiac tamponade (requiring pericardiocentesis and medication) and thrombosis.During the case, fluoroscopy guided epicardial access on the chest below the sternum was gained with a st.Jude agilis epi 8.5f device.Then, the pentaray nav high-density mapping eco catheter was introduced to the pericardium and used for mapping the left ventricle and right anterior ventricle.A sudden drop in patient¿s blood pressure occurred (110 systolic to 66 systolic) whilst mapping the very large scar and aneurism area of the right ventricle.Cardiac tamponade was then confirmed by ultrasound, and a pericardiocentesis was performed to remove 800ml of venous blood.Protamine medication was also administered.Patient¿s condition worsened and developed clotting in several veins.Extended hospitalization was required to treat the clotted veins, the treatment performed was not specified; however, it was confirmed that surgical intervention was not required.The patient was admitted into the intensive care unit (icu) and was reported in stable condition.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 related to the reported complaint were identified.The customer complaint cannot be confirmed.The root cause of the adverse event remains unknown.The catheter passed all specifications.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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 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: 9886310
• MDR Text Key: 191595651
• Report Number: 2029046-2020-00481
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30322298L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; NON BWI -ST. JUDE AGILIS EPI 8.5F; THMCL SMTCH SF UNID, TC, D
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention