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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. PENTARAY NAV HIGH-DENSITY MAPPING CATHETER; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
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BIOSENSE WEBSTER, INC. PENTARAY NAV HIGH-DENSITY MAPPING CATHETER; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY Back to Search Results
Catalog Number D128208
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2016
Event Type  malfunction  
Event Description
Cardiac catheter's sensor did not work properly after inserting into patient's body.Troubleshooting done by disconnecting the catheter and tried a new cable as well; therefore, we had to use new (pentaray) catheter.Ep reviewed.It was a catheter malfunction.When the catheter was connected to the cable, there was no signal displayed.Changed the cable first, but there was still no signal.The catheter was removed, and a new catheter was inserted.The new catheter worked fine and had signal displayed.The procedure completed without further issues, and no injury to the patient.
 
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Brand Name
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
Type of Device
CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
Manufacturer (Section D)
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd
diamond bar CA 91765
MDR Report Key5909854
MDR Text Key53332890
Report Number5909854
Device Sequence Number1
Product Code MTD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2016
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberD128208
Device Lot Number17185222L
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/24/2016
Event Location Other
Date Report to Manufacturer08/24/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age63 YR
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