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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY Back to Search Results
Catalog Number D128208
Device Problems Entrapment of Device (1212); Device Issue (2379)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2018
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 17758398l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures. Concomitant product: 1. Carto 3, us catalog #: fg540000m, serial #: (b)(4). Manufacturer's ref. No: (b)(4).

 
Event Description

It was reported that a patient underwent an ablation procedure for ventricular tachycardia with a pentaray nav high-density mapping eco catheter. While mapping the left ventricle with the pentaray nav high-density mapping eco catheter, the deflection mechanism broke and was stuck in the deflected position. Physician was unable to relax the deflection. The pentaray nav high-density mapping eco catheter was removed under x-ray guidance. The procedure was completed with no patient consequence. The medical device entrapment issue was assessed as not reportable. The device was able to be removed without surgical intervention. The potential risk that it could cause or contribute to a serious injury or death to the patient was remote. The catheter being stuck in a deflected position was assessed as a reportable malfunction.

 
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Brand NamePENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
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
gabriel alfageme
33 technology drive
irvine, CA 92618
949789-868
MDR Report Key7286065
MDR Text Key100897058
Report Number2029046-2018-01230
Device Sequence Number1
Product Code MTD
Combination Product (Y/N)N
Reporter Country CodeAS
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,Followup
Report Date 01/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/01/2020
Device Catalogue NumberD128208
Device LOT Number17758398L
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/01/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/02/2017
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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