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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV ECO 7FR, D, 2-6-2 CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

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BIOSENSE WEBSTER INC PENTARAY NAV ECO 7FR, D, 2-6-2 CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY Back to Search Results
Catalog Number D128211
Device Problems Device Issue (2379); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/27/2017
Event Type  Malfunction  
Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a. Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. The device history record (dhr) for the lot number 17750921l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures. (b)(4).

 
Event Description

It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter. It was reported that a current leakage alert was displayed on the system. The catheter was replaced and the procedure continued. No patient consequences were reported. Additional information was received which clarified that the current leakage error was displayed due to a signal noise issue. The signal noise was observed on all channels on the carto 3 system and the recording system. It was also confirmed that the physician did not have any ecg signal available to monitor the patient¿s heart rhythm. The current leakage alert was assessed as not reportable as it is highly detectable and requires adjusting system components to continue with the procedure. Devices may require reset or replacing but cannot be used on the patient. Patient safety is unaffected by this issue. The signal noise issue was assessed as a reportable malfunction.

 
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Brand NamePENTARAY NAV ECO 7FR, D, 2-6-2
Type of DeviceCATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
Manufacturer (Section D)
BIOSENSE WEBSTER INC
33 technology drive
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER INC (JUAREZ)
circuito interior norte
1820parque industrial salvacar
juarez 32599
MX 32599
Manufacturer Contact
joaquin kurz
33 technology drive
irvine, CA 92618
949789-383
MDR Report Key7212467
MDR Text Key98287360
Report Number2029046-2018-01089
Device Sequence Number1
Product Code MTD
Combination Product (Y/N)N
Reporter Country CodeTW
PMA/PMN NumberK123837
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/16/2020
Device Catalogue NumberD128211
Device LOT Number17750921L
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/27/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/17/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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