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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
Model Number D134805
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2019
Event Type  malfunction  
Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).
 
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.It was reported that during the procedure a thrombus was found on the electrode tip.The catheter was exchanged for another thermocool® smart touch® sf bi-directional navigation catheter and the issue was resolved.The procedure was completed without patient consequence.
 
Manufacturer Narrative
On 1/16/2020, the bwi product analysis lab received the complaint device for evaluation.Initial visual analysis observed a brown/red material on the dome perceived to be evidence of a thrombus formation.This finding was assessed as mdr reportable and is consistent with the customer¿s reported complaint ¿thrombus on the electrode tip.¿ the file continues to be mdr reportable.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, if other 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 an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.It was reported that during the procedure a thrombus was found on the electrode tip.The catheter was exchanged for another thermocool® smart touch® sf bi-directional navigation catheter and the issue was resolved.The procedure was completed without patient consequence.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found reddish-browm material on the dome.During a closer inspection, thrombus was confirmed on the dome.The temperature feature was tested and no issues were observed.In addition, the catheter was irrigating correctly.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint regarding thrombus has been confirmed.The root cause of the thrombus reported by the customer could be related to the usage of the device during the procedure, however, this cannot be conclusively determined.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
On (b)(6) 2019, biosense webster inc.Received additional information indicating a smartablate generator was used during the procedure.The device has been added to section d11.Concomitant med.Products.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).
 
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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 Key9509212
MDR Text Key200055484
Report Number2029046-2019-04057
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,Followup
Report Date 12/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2020
Device Model NumberD134805
Device Catalogue NumberD134805
Device Lot Number30276839M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2020
Date Manufacturer Received02/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SMARTABLATE GEN. KIT (JAPAN).
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