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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184); Device Sensing Problem (2917); Device-Device Incompatibility (2919); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.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).

Event Description

It was reported that a female patient (around (b)(6) year-old/around (b)(6) lbs) underwent a cardiac ablation procedure for persistent atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.Patient was under general anesthesia.At 9:45am the first transseptal puncture was performed with an abbot brk transseptal needle.The wire and stsf catheter were parked in the left atrial appendage (laa).The temperature of the stsf was displayed on the smartablate generator very sporadically.The ablation signals were not clear and there was a lot of noise seen from the intracardiac (ic) signals on the carto 3 system and the recording system.Defibrillator and anesthesia monitors were available to monitor patient¿s heart rhythm.A new stsf catheter was opened in the sterile field.Mapping was done to the left atrium (la) with a pentaray nav high-density mapping eco catheter.It was also reported that the distal electrode of the was blacked out on the carto 3 system.The cable was exchanged, and it appeared to be resolved but the electrode signal would flicker in and out.At 10:00am (before the stsf catheter could be exchanged with the one already was in the sterile field), the certified registered nurse anesthetists (crna) noticed, the patient became hypotensive and cardiac tamponade was confirmed by ultrasound.Pericardiocentesis was performed to drain about 600cc of fluid from the pericardial space.Reminder of the procedure was cancelled.The patient was reported in stable condition and was transferred to the cardiac intensive care unit for observation.Prolonged hospitalization was required.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.The catheter, which was not quite connected to the carto 3 system, was not visualized via the carto 3 system but it was seen on fluoro.The physician continued advancing the catheter, but he felt resistance as he was advancing it inside the heart.The physician felt this may have caused the effusion.Catheter irrigation was set at 2ml/min.Graph, vector and dashboard were used as force visualization features.Visitag was not used as no ablation was able to be performed.Force was use as coloring option.The resistance felt while advancing the stsf into the heart will not be coded as a product deficiency as it is most likely related to the inability to visualize the catheter through the carto 3 system which made it difficult to be introduced.Since this event is life threatening and required intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 2/23/2021, the product investigation was completed.It was reported that a female patient (around 67 to 75 year-old/around 150 lbs) underwent a cardiac ablation procedure for persistent atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.Patient was under general anesthesia.At 9:45am the first transseptal puncture was performed with an abbot brk transseptal needle.The wire and stsf catheter were parked in the left atrial appendage (laa).The temperature of the stsf was displayed on the smartablate generator very sporadically.The ablation signals were not clear and there was a lot of noise seen from the intracardiac (ic) signals on the carto 3 system and the recording system.Defibrillator and anesthesia monitors were available to monitor patient¿s heart rhythm.A new stsf catheter was opened in the sterile field.Mapping was done to the left atrium (la) with a pentaray nav high-density mapping eco catheter.It was also reported that the distal electrode of the was blacked out on the carto 3 system.The cable was exchanged, and it appeared to be resolved but the electrode signal would flicker in and out.At 10:00am (before the stsf catheter could be exchanged with the one already was in the sterile field), the certified registered nurse anesthetists (crna) noticed, the patient became hypotensive and cardiac tamponade was confirmed by ultrasound.Pericardiocentesis was performed to drain about 600cc of fluid from the pericardial space.Reminder of the procedure was cancelled.The patient was reported in stable condition and was transferred to the cardiac intensive care unit for observation.Prolonged hospitalization was required.Device evaluation details: the device was visually inspected and it was found in good normal conditions.Per the complaint, several test were performed.A deflection test was performed and the catheter was found within specifications.Also, sensor functionality was tested on carto 3 system and no anomalies were observed.Then, stockert generator compatibility was tested and no temperature nor impedance issues were detected.Next to it, an electrical test was performed and no electrical malfunction was observed.Next, catheter irrigation was tested and no irrigation issues were detected.Finally an od test was performed and the catheter diameters were found within specifications.A manufacturing record evaluation was performed for the finished device 30452544m number, and no internal actions related to the reported complaint condition were identified.The customer complaint regarding the adverse event cannot be duplicated as intended.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The device is working in specification.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: 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: 11314283
• MDR Text Key: 238692903
• Report Number: 2029046-2021-00150
• 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
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30452544M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOT BRK TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; PENTARAY NAV ECO; SMARTABLATE GENERATOR; THERMOCOOL SMARTTOUCH; UNSPECIFIED RECORDING SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention