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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Date of event has been left blank because event date is unknown.(b)(4).Biosense webster manufacturer's reference number (b)(4) has two reports: mfr # 2029046-2020-01784 for product code ni75tcdh (navi-star¿ thermo-cool¿ electrophysiology catheter).Mfr # 2029046-2020-01785 for product code d7l1015ct (lasso¿ electrophysiology catheter with auto id).

Event Description

It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and a lasso¿ electrophysiology catheter with auto id and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.After the transseptal puncture with an abbot brk1 transseptal needle, the lasso¿ electrophysiology catheter with auto id was positioned in the left atrium (la).The physician performed an angiography of the pulmonary veins using a multipurpose sheath.While manipulating the sheath in the la, the patient became hypotensive and cardiac tamponade was confirmed by echography.Pericardiocentesis was performed to drain the blood from the pericardial space.After a short while, the patient stabilized, and the procedure was continued.Ablation was performed with a navi-star¿ thermo-cool¿ electrophysiology catheter.Towards the end of the procedure, the patient¿s blood pressure dropped again, and the situation got critical and the bleeding could not be stopped anymore, so the patient was immediate transferred to cardiac surgery on which an endocardial injury at the base of the left atrial appendage (laa) was confirmed.After surgery, patient¿s condition improved, and she was sent to the intensive care unit (icu).Prolonged hospitalization was required.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related, he believed the second event occurred after the ablation was related to the first one and he thinks the initial injury got bigger during catheter manipulation in the area of the appendage.He did not attribute the causality of the event to the bwi products.Catheter irrigation was set at 20ml/min.No bwi product malfunctions nor error messages were reported.The parameters for stability used included 3mm / time: 10sec / no force / tag size: 2mm.Total time was used as coloring option.With the information available, it could be that the adverse event occurred due to the transseptal puncture; however, since the event was noticed after the lasso catheter was already placed into the la, it cannot be excluded; hence, the event is being conservatively coded and reported under the lasso catheter.This event s being also coded and reported under the navistar catheter since the initial injury got bigger while manipulating the navistar catheter in the laa during the ablation; therefore, this catheter cannot be either excluded.

Manufacturer Narrative

It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and a lasso¿ electrophysiology catheter with auto id and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.After surgery, patient¿s condition improved, and she was sent to the intensive care unit (icu).Prolonged hospitalization was required.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related, he believed the second event occurred after the ablation was related to the first one and he thinks the initial injury got bigger during catheter manipulation in the area of the appendage.He did not attribute the causality of the event to the bwi products.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number 30381189m identified no internal actions related to the reported complaint condition.Still no device has been received for analysis, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Based on the completed mre, field d4.Expiration date has been populated as 4/19/2023 and field h4.Device manufacture date has been populated with 4/20/2020.Additionally, the event date was reported as 10/20/2020.Field b3.Date of event has been populated.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.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10867384
• MDR Text Key: 217093067
• Report Number: 2029046-2020-01784
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: 10846835000559
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2023
• Device Model Number: NI75TCDH
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 30381189M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOT BRK1 TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; UNKNOWN MULTIPURPOSE SHEATH; ABBOT BRK1 TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; UNKNOWN MULTIPURPOSE SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention