MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. SMARTABLATE SYSTEM IRRIGATION PUMP; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number M4900109

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

Patient Problem Air Embolism (1697)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

Attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product investigation can be performed and the customer complaint cannot be confirmed.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.Manufacturing record evaluation (mre) cannot be conducted because no lot/serial number was provided by the customer.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with a smartablate¿ system irrigation pump and suffered ischemic changes (st segment elevation) due to air embolism requiring adrenaline injection and defibrillation.It was initially reported by the customer that a visualization issue was encountered with the decanav catheter.Even though the visualization matrix was built, the decanav catheter kept disappearing and/or displayed in the wrong location (outside the accuracy area).This was confirmed by real catheter position through fluoroscopy imaging.The issue persisted even after the insertion of the ablation catheter (smarttouch ablation catheter) inside the right atrium.Changing the cable twice (with the second cable being a completely new cable) did not solve the issue.The pulmonary vein isolation (pvi) procedure was interrupted before changing the catheter and before the catheter was positioned in the left atrium because the anesthesia team noticed an st elevation in the inferior ecg leads (indication of coronary embolism) and a significant blood drop.After adrenaline injection, patient went first to ventricular tachycardia and then to ventricular fibrillation.Patient was therefore successfully defibrillated.After clinical assessment of the situation, the physicians determined that the air bubble most probably came from a catheter sheath (not bwi product) and traveled to the left side through a pre-existent potent foramen ovale (pfo).The physician states that the ablation catheter (thermocool smart touch bidirectional) was flushed before it was inserted in the patient.The pvi procedure was postponed.Patient left the room stable and in sinus rhythm.Biosense webster will conservatively report the adverse event under the smartablate¿ system irrigation pump.The customer¿s reported catheter visualization issues are not mdr reprotable since the potential risk that it could cause or contribute to a serious injury or death is remote.

Manufacturer Narrative

On 3/9/2020, additional information about the event was received.It was reported the patient involved was a male patient.The model of the non-bwi sheath is unknown and the way it was irrigates is unclear.The catheters were inserted into the right atrium, but they never were positioned in the left atrium.This adverse event was discovered during use of biosense webster products.The physician¿s opinion is that the nature of the procedure or the patient¿s condition is the most likely etiology of the event.No surgical intervention was required.No extended hospitalization was required.The patient had fully recovered.The correct product information such as the serial number of the smartablate¿ system irrigation pump involved in the case was also received.As such, the following updates have been processed in the respective fields: d2.2.A.Common device name has been changed from cardiac ablation percutaneous catheter to similar device m490008, pma # p990071/s017.D4.Serial # has been populated with g4cp-2736.D4.Catalog # has also been updated from unk_smartablate pump to m4900109.G1.Manufacturing site name changed from biosense webster inc (juarez) to biosense webster inc (irwindale).G1.Manufacturer site addr.Street line 1 changed from circuito interior norte to 15715 arrow highway.G1.Manufacturer site addr.Street line 2 changed from 1820parque industrial salvacar to blank.G1.Manufacturer site city changed from juarez to irwindale.G1.Manufacturer site state code changed from blank to ca.G1.Manufacturer site zip code changed from 32599 to 91706.G1.Manufacturer site country code changed from mex to usa.G1.Manufacturer site postal code changed from 32599 to 91706.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with a smartablate¿ system irrigation pump and suffered ischemic changes (st segment elevation) due to air embolism requiring adrenaline injection and defibrillation.The anesthesia team noticed an st elevation in the inferior ecg leads (indication of coronary embolism) and a significant blood drop.After adrenaline injection, patient went first to ventricular tachycardia and then to ventricular fibrillation.Patient was therefore successfully defibrillated.After clinical assessment of the situation, the physicians determined that the air bubble most probably came from a catheter sheath (not bwi product) and traveled to the left side through a pre-existent potent foramen ovale (pfo).The physician states that the ablation catheter (thermocool smart touch bidirectional) was flushed before it was inserted in the patient.The pvi procedure was postponed.Patient left the room stable and in sinus rhythm.Biosense webster will conservatively report the adverse event under the smartablate¿ system irrigation pump.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).A manufacturing record evaluation was performed for the finished device with serial number (b)(6), and no internal action related to the reported complaint condition were identified.Multiple follow-up attempts have been completed to obtain product return status to no avail.Since product has not been returned for repair and service no further product investigation can be performed, and the customer complaint cannot be confirmed.No further information has been made available.The h4.Device manufacture date has been populated with 10/10/2017.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: SMARTABLATE SYSTEM IRRIGATION PUMP
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9783352
• MDR Text Key: 191686618
• Report Number: 2029046-2020-00348
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 02/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M4900109
• Initial Date Manufacturer Received: 02/09/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 03/09/2020; 09/25/2020
• Supplement Dates FDA Received: 04/03/2020; 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7FR DECAN,11P,F,2.4MMLE,282MM,; THMCL SMRTTCH,BI,NAV,TC,D-F,C3; UNKNOWN CATHETER SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention