MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

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

Patient Problems Air Embolism (1697); Cardiac Arrest (1762)

Event Date 08/26/2020

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, a manufacturing record evaluation was performed for the finished device 30360533l number, and no internal action related to the complaint was found during the review.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 male patient underwent cardiac ablation for atrial fibrillation with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac arrest requiring cardiopulmonary resuscitation (cpr).Theater and carto 3 equipment were setup as usual.Access via femoral vein was obtained and catheters were inserted into the right atrium (ra).A double transseptal was performed (abbott sl0 fixed sheath and an abbott transseptal needle) to access the left atrium (la).Left atrium was briefly mapped with lasso catheter.Then when trying to map with an ablation catheter, physician observed that the angle of transseptal sites were not in a workable location so they went and performed another puncture through atrial septum.After the new transseptal puncture was performed and catheters were about to be re-introduced in the body, patient´s blood pressure suddenly dropped.Heparine infusion was stopped, adrenaline was administered and cpr was initiated.The procedure was aborted.Cardiac echography and transesophageal echo (toe) showed no cardiac tamponade.Patient was stabilized and transfer to intensive care unit (icu).Patient was monitored throughout with arterial blood pressure line, saturation probe and ecg's on ep recording system, anaesthetic equipment and external defibrillator.Physician¿s opinion is that it was possible that a small embolism might have occurred in one of the coronary arteries when introducing or flushing fixed sheaths (abbot swartz sl0 sheath) into left side of the heart.No fragments were generated.The patient remained in observation for one (1) day in icu.No biosense webster product malfunctioned, hence no service has been requested.

Manufacturer Narrative

During an internal review of the reported event (b)(6) 2020, it¿s been determined that since the left atrium was just accessed prior to the event via transseptal and no catheters were inside the abbott sl0 fixed sheath, it is safe to consider the thermocool® smart touch® sf bi-directional navigation catheter a concomitant device in this event.As such, the abbott sl0 fixed sheath is the suspected device contributing to the adverse event.This event will no longer be considered to be mdr reportable against any biosense webster inc.Devices.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: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10578128
• MDR Text Key: 215490450
• Report Number: 2029046-2020-01321
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30360533L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOT SWARTZ SLO SHEATH; ABBOTT TRANSEPTAL NEEDLE; CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; LASSO NAV 2515,22P SPLITHANDLE; SMARTABLATE PUMP KIT-WW; SMARTABLATE PUMP KIT-WW; UNKNOWN ANAESTHETIC EQUIPMENT; UNKNOWN EP RECORDING SYSTEM; UNKNOWN EXTERNAL DEFIBRILLATOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 68 YR