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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

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BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Catalog Number NI75TCDH
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Cardiac Perforation (2513)
Event Type  Injury  
Manufacturer Narrative
E1.Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation with a navi-star¿ thermo-cool¿ electrophysiology catheter and the patient experienced cardiac perforation that required surgical intervention and prolonged hospitalization.It was reported that pericardial tamponade was noticed after ablation.Blood was drained and given back to patient.The physician's assessment was that the tamponade happened during transseptal puncture (tsp).Patient experienced blood loss and pain.The patient was moved to the "chest pain unit" after procedure.Additional update from the hospital was received on (b)(6) 2024 morning.The patient required open heart surgery after the procedure.The puncture/tamponade was in the left ventricular (lv) apex.The head of electrophysiology assumes this is due to the use of a non-contact force catheter and has asked the operator to use contact force catheters in the future.The physician's opinion on the cause of this adverse event was that it was procedure related.A fairly large amount of mapping and ablation were performed with a non-contact force sensing catheter.Patient has improved.Patient required extended hospitalization as the patient required open heart surgery to stabilize and had to stay for recovery.No steam pop was noted.No error messages observed on biosense webster inc.(bwi) equipment during the procedure.Location of the perforation was in the lv apex.Cardiac perforation was confirmed.
 
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Brand Name
NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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
kate karberg
31 technology dr
irvine, CA 92618
3035526892
MDR Report Key18611825
MDR Text Key334140208
Report Number2029046-2024-00354
Device Sequence Number1
Product Code OAD
UDI-Device Identifier10846835000559
UDI-Public10846835000559
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P030031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberNI75TCDH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/08/2024
Initial Date FDA Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ABBOTT BRK NEEDLE; NGEN RF GENERATOR; UNK PUMP; UNK_CARTO 3
Patient Outcome(s) Hospitalization; Required Intervention; Life Threatening;
Patient SexMale
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