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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. NAVISTAR RMT THERMOCOOL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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BIOSENSE WEBSTER INC. NAVISTAR RMT THERMOCOOL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number NR7TCSIY
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Cardiac Tamponade (2226)
Event Date 12/02/2020
Event Type  Injury  
Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
 
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure transseptal puncture was performed with a brk needle, and the ablation was done with the navistar catheter.After ablation, there was difficulty on moving the catheter.It was then noticed that the patient¿s blood pressure dropped.Cardiac tamponade was confirmed by ultrasound.Pericardiocentesis was performed and 200cc of fluid was drained.The patient was reported in stable condition after pericardial drainage and recovered normally.Prolonged hospitalization was not required.Physicians¿ opinion is that the event occurred due to poor transseptal puncture.No bwi product malfunction nor error messages were reported.There was no evidence of steam pop during the ablation.The catheter flow was set between 15-30 ml/min.
 
Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure transseptal puncture was performed with a brk needle, and the ablation was done with the navistar catheter.After ablation, there was difficulty on moving the catheter.It was then noticed that the patient¿s blood pressure dropped.Cardiac tamponade was confirmed by ultrasound.Pericardiocentesis was performed and 200cc of fluid was drained.The patient was reported in stable condition after pericardial drainage and recovered normally.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 (mre) cannot be conducted because an invalid lot number was provided by the customer.Multiple attempts have been made to obtain clarification on the lot number provided.However, no further information has been made available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: it was noticed that the e1.Initial reporter details were inadvertently omitted from the 3500a initial medwatch report.Dr.(b)(6); (b)(6) has been added to the appropriate fields in section e.
 
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Brand Name
NAVISTAR RMT THERMOCOOL ELECTROPHYSIOLOGY CATHETER
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
33 technology drive
irvine CA 92618
MDR Report Key11093437
MDR Text Key224366897
Report Number2029046-2020-02010
Device Sequence Number1
Product Code OAD
UDI-Device Identifier10846835008500
UDI-Public10846835008500
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
Type of Report Initial,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberNR7TCSIY
Device Catalogue NumberNR7TCSIY
Device Lot Number3042597M
Was Device Available for Evaluation? No
Date Manufacturer Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BRK NEEDLE; CARTO 3 SYSTEM; REPROCESSED SOUNDSTAR; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; UNK_PENTARAY; BRK NEEDLE; CARTO 3 SYSTEM; REPROCESSED SOUNDSTAR; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; UNK_PENTARAY
Patient Outcome(s) Life Threatening; Required Intervention;
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