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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. PENTARAY NAV; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY

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BIOSENSE WEBSTER INC. PENTARAY NAV; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY Back to Search Results
Model Number D128208
Device Problem Use of Device Problem (1670)
Patient Problem No Information (3190)
Event Date 09/25/2018
Event Type  malfunction  
Event Description
A catheter sensor error came across during an ablation case.The cable was switched out but no resolution so another catheter was used and worked fine.
 
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Brand Name
PENTARAY NAV
Type of Device
CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
5110 commerce rd.
baldwin park CA 91706
MDR Report Key7960121
MDR Text Key123556353
Report Number7960121
Device Sequence Number1
Product Code MTD
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 10/02/2018,09/26/2018
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 NumberD128208
Device Catalogue NumberD128208
Device Lot Number30078030L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/02/2018
Event Location Hospital
Date Report to Manufacturer10/12/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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