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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. LASSO ECO CATHETER; CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE
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BIOSENSE WEBSTER INC. LASSO ECO CATHETER; CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE Back to Search Results
Model Number D74015CT AND EM5050060
Device Problems Break (1069); Unable to Obtain Readings (1516)
Patient Problem Insufficient Information (4580)
Event Date 03/03/2020
Event Type  malfunction  
Event Description
We are reporting a total of (b)(4) events with different models of electrophysiological ablation catheters by biosense webster, which occurred in the past year.In this report, we are reporting (b)(4) out of the (b)(4) events, 2 lasso atrial fibrillation ablation catheters malfunctioned.The details are as below: brand name: lasso eco cable, model/catalog #: em5050060, lot number: na malfunction: broken connector shell.Lasso catheter(with auto id), d74015ct, 30254801l, no readings electrode.
 
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Brand Name
LASSO ECO CATHETER
Type of Device
CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
5110 commerce rd.
baldwin park CA 91706
MDR Report Key11258060
MDR Text Key229620992
Report Number11258060
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberD74015CT AND EM5050060
Device Catalogue NumberD74015CT AND EM5050060
Device Lot Number30254801L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/13/2021
Event Location Hospital
Date Report to Manufacturer02/01/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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