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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER
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BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Catalog Number D134805
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Cardiac Tamponade (2226)
Event Date 04/01/2019
Event Type  Injury  
Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.On 5/2/2019, a manufacturing record evaluation was performed for the finished device and no internal actions were found during the review.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Reports 2029046-2019-03235 are related to this same incident.Manufacture reference no: (b)(4).
 
Event Description
It was reported that a male patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) and a thermocool® smart touch® sf uni-directional navigation catheter and developed pericarditis and cardiac tamponade requiring pericardiocentesis.Initially it was reported that during the procedure it was noted that after several radio frequency applications with the stsf catheter, the catheter temperature dropped from 32c to 16c and the catheter handle was warmer than usual.The cable was exchanged without resolution.The stsf catheter was then replaced with an unknown catheter, which worked well, and the procedure was completed.After the patient left the lab, it was then noted the patient suffered pericardial effusion and pericarditis.The initial observed low temperature and warm handle was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The observed pericardial effusion and pericarditis was assessed as not mdr reportable as there was no indication that a medical and or surgical intervention was performed.It was reported that the stsf catheter was replaced by an unknown product and confirmed that the product information is not available.Therefore a generic stsf device will be used in order to address the patient consequences under both products, as two different catheters were used during the case.Clarification was then received on 5/13/2019, indicating the patient actually had cardiac tamponade in addition to the pericarditis.Thereafter, pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.Extended hospitalization was required as a result of the adverse event.Patient¿s outcome was fully recovered with no residual effects.The patient¿s outcome was fully recovered with no residual effects and the physician¿s opinion regarding the cause of the adverse event is that it was patient condition-related.Transseptal puncture was performed during the case.The irrigation was set at 2ml/min during mapping, and 15ml/min during the ablation phase.No error messages were observed on any biosense webster inc.(bwi) equipment during the case.The catheter was zeroed after the initial warm-up phase post catheter connection to the carto® 3 patient interface.The carto 3 system did not indicate to re-zero the catheter.The issue of cardiac tamponade and pericarditis has been assessed as mdr reportable as the adverse event required medical treatment.The awareness date has been reset to 5/13/2019.
 
Manufacturer Narrative
It was reported that a male patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) and a thermocool® smart touch® sf uni-directional navigation catheter and developed pericarditis and cardiac tamponade requiring pericardiocentesis.On 6/11/2019, biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation.Upon initial visual inspection, the product revealed no physical damage.Section device available for evaluation of this report has been updated.Manufacture ref no: (b)(4).
 
Manufacturer Narrative
It was reported that a male patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) and a thermocool® smart touch® sf uni-directional navigation catheter and developed pericarditis and cardiac tamponade requiring pericardiocentesis.The investigational analysis completed(b)(6)2019.The device was visually inspected and it was found in good conditions.The magnetic sensor was tested on carto and the catheter was properly visualized.With no errors were observed.The force sensor was tested and it was working properly.The force values were observed within specifications.Electrical testing was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator.The temperature and impedance values were observed within specifications.Irrigation and deflection testing was performed and was found within specifications.The catheter was irrigating and deflecting correctly.During the test, no temperature issue with the handle was observed.A manufacturing record evaluation was performed and no internal actions were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition-related.The instructions for use state that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacture ref no: pc-000441984.
 
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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 Key8677057
MDR Text Key147314964
Report Number2029046-2019-03234
Device Sequence Number1
Product Code LPB
UDI-Device Identifier10846835010183
UDI-Public10846835010183
Combination Product (y/n)N
PMA/PMN Number
P030031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/28/2019
Device Catalogue NumberD134805
Device Lot Number30149338L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Date Manufacturer Received07/07/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
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