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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 patient ((b)(6)) underwent cardiac ablation procedure for ventricular ectopy with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure there were multiple issues with carto software: - very slow point acquisition, up to 3secs delay and made it frustrating to run.The advanced reference annotation (ara) ventricular set up and it was tagging every beat but it just was too slow.Respiration filter was not enabled on in any confidence settings and the same thing was happening even with a map set up with no confidence settings.Manual acquisition was just too slow to be functional.Paso points/tags set to lo in settings for automation.Lo tagging yet were still adding local activation time (lat) information to the map.When shown a paso correlation map in one window and a lat map in the other (didn¿t matter which was the main map) the lat color bar reflected the lo timings from our paso tags.When both maps were lat only this issue resolved to the correct lat min and max timings.Parallel mapping was attempted at the beginning and when set the individual window of interest (woi) for each map, it changed all the maps linked in the groups woi.It did this even when parallel mapping was deactivated.Pattern matching correlations were being propagated in the point list without pattern matching enabled for that case.Annotation was set to wavefront and yet every point take was considered a no lat point and so the clinical specialist had to keep manually set lat for each point.Even thought the distal unipolar electrocardiogram (egm) was huge and the signal was huge.Noise floor was set to 0.1.But the signal was 0.28mv and still was sating it was a no lat point.No other filters were applied (is map consistency, etc).The yellow annotation line and dot would disappear and reappear and sometimes there was just no dot, only the dashed line.- patches were disconnected with no alerts or errors shown.Smart ablate generator had a "indifferent electrode not deleted error" but was still reading impedance.The indifferent patch was replaced and error resolved.The procedure was aborted as the physician lost all faith in the system to perform safely and effectively.The patient was to be brought back another day with another system.At this point upon removing the catheters and sheaths at the end of the procedure the electrophysiology fellow noticed that the patient appeared grey in color and subsequently preformed a fluoroscopy of the heart shadow that indicated the patient was suffering a cardiac tamponade.Physician gained arterial access and performed pericardiocentesis, draining approximately 150mls of blood.The patient was stabilized and was transferred to flinders medical centre icu for observation.During the procedure a thermocool smarttouch stsf catheter was used in the right ventricular outflow tract (rvot) and a abbott cs deca catheter in addition to a abbott his catheter.Midway through the procedure there was high force on his catheter and the physician he repositioned his catheter accordingly.Transseptal was not performed.Only a couple of applications of energy were given before cancelling the procedure.There was no evidence of steam pop.Catheter setting were 30w and flow rate of 8ml/min.The patient was under sedation with anesthetist.In the physician¿s opinion, cancellation of the procedure did not contribute to a serious injury to the patient.The patient remained in the hospital over a weekend.The patient had fully recovered.Dashboard and vector force visualization modules were used.The event cardiac tamponade is conservatively reported under the ablation catheter.Since cardiac tamponade may be life threatening it is mdr-reportable.

Manufacturer Narrative

On 5/10/2021, the product investigation was completed as the complaint device was not returned.It was reported that a patient (62 year old) underwent cardiac ablation procedure for ventricular ectopy with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30430130l 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 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: 11075013
• MDR Text Key: 223799556
• Report Number: 2029046-2020-01989
• 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: 12/04/2020

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 Expiration Date: 08/23/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30430130L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT CS DECA CATHETER.; ABBOTT HIS CATHETER.; CARTO 3 SYSTEM.; SMARTABLATE GENERATOR.; UNSPECIFIED SHEATH.; ABBOTT CS DECA CATHETER; ABBOTT HIS CATHETER; CARTO 3 SYSTEM; SMARTABLATE GENERATOR; UNSPECIFIED SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR