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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 SIMILAR DEVICE D133601, PMA # P030031/S053

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BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 Back to Search Results
Catalog Number D133605IL
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Positioning Problem (3009); Patient Device Interaction Problem (4001)
Patient Problem Cardiac Tamponade (2226)
Event Date 05/27/2021
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. 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 a male patient underwent an atrial fibrillation (afib) ablation procedure with a two (2) thermocool® smart touch® sf bi-directional navigation catheter. The patient suffered cardiac tamponade requiring pericardiocentesis. Force issue & deflection issue. Pericardial tamponade occurred. During the operation of persistent af, the force was unstable after the catheter was zeroed. Then the device was repeated displayed to zero correction. The highest force reached 40-50 g. During the process of ablation, a steam pop occurred twice (force did not change significantly during the period of pop). Force was still not stable one hour after ablation. Switched another catheter to ablate for 0. 5h, physician found that the catheter was unable to deflect or relax completely. Pericardial tamponade occurred, observed some pericardial effusion, blood pressure (80/50mmhg) and oxygen saturation decreased, performed a pericardial puncture immediately, drained pericardial effusion. Fifteen minutes later, the patient was awake. Surgeon changed the third catheter, continued to ablate for about 10 minutes, then completed the procedure. The patient was transferred to the general ward. Patient had no pericardial effusion today and was stable. Steam pop is not mdr-reportable. The deflection issue is not mdr-reportable. The force issue is not mdr-reportable. Since the cardiac tamponade is life-threatening and might result in permanent impairment of a body function or permanent damage of a body structure, it is to be considered serious and mdr-reportable. This report is for the second of 2 mdr-reportable thermocool® smart touch® sf bi-directional navigation catheters. The 1st catheter was reported under manufacturer reporter number 2029046-2021-00952.
 
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Brand NameTHERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
Type of DeviceSIMILAR DEVICE D133601, PMA # P030031/S053
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
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 dr
irvine, CA 92618
9497898687
MDR Report Key12030362
MDR Text Key263455436
Report Number2029046-2021-00953
Device Sequence Number1
Product Code LYB
Combination Product (y/n)N
Reporter Country CodeCH
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 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberD133605IL
Device Lot Number30515026M
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 Received07/06/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/09/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/20/2021 Patient Sequence Number: 1
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