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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053

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BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 Back to Search Results
Catalog Number UNK_SMART TOUCH BIDIRECTIONAL
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problem Cardiac Tamponade (2226)
Event Date 09/15/2020
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 underwent cardiac ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch¿ bi-directional navigation catheter and suffered cardiac tamponade. At the beginning of afib ablation procedure, the physician wanted to start fast anatomical mapping (fam) view but when zoomed in, the fam disappeared. Visualization matrix is not built, ablation catheter disappeared in the background, went black. The physician zoomed in and couldn't see anything. When the physician zoomed out, they regained vision again. The physician performed a cavotricuspid isthmus (cti) ablation in the right atrium at 50 watts with the thermocool® smart touch¿ bi-directional navigation catheter. After 30 seconds of ablating, a steam pop occurred. At the end of the procedure, the patient went to recovery room in apparently normal condition. However, when the physician came back to check on the patient 50 minutes later, he had noticed a tamponade. No further information has been made available. The visualization issue is not mdr-reportable. The steam pop is not an mdr-reportable issue. Cardiac tamponade may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable.
 
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Brand NameTHERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER
Type of DeviceSIMILAR DEVICE D132701, PMA # P030031/S053
Manufacturer (Section D)
BIOSENSE WEBSTER INC
33 technology drive
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER INC (JUAREZ)
circuito interior norte
1820parque industrial salvacar
juarez 32599
MX 32599
Manufacturer Contact
gabriel alfageme
31 technology drive
irvine, CA 92618
949789-868
MDR Report Key10666545
MDR Text Key211885288
Report Number2029046-2020-01469
Device Sequence Number1
Product Code LYB
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P030031/S053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SMART TOUCH BIDIRECTIONAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/12/2020 Patient Sequence Number: 1
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