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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. LASSO 2515; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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BIOSENSE WEBSTER INC. LASSO 2515; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Catalog Number D134302
Device Problem Insufficient Information (3190)
Patient Problem Pericardial Effusion (3271)
Event Date 05/16/2014
Event Type  No Answer Provided  
Event Description
During atrial fibrillation ablation, steam pop sound was heard during radio frequency application.The patient subsequently developed a pericardial effusion, which required additional medical intervention and hospitalization.The physician/staff involved in the procedure do not know what caused the problem.All are experienced in this type of procedure and with this equipment.
 
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Brand Name
LASSO 2515
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
3333 diamond canyon rd
diamond bar, CA 91765
MDR Report Key3873884
MDR Text Key15363543
Report Number3873884
Device Sequence Number1
Product Code DRF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/27/2014
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue NumberD134302
Device Lot Number16044550L
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/27/2014
Event Location Hospital
Date Report to Manufacturer06/16/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/27/2014
Patient Sequence Number1
Treatment
OTHER
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age76 YR
Patient Weight99
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