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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER, INC. (JUAREZ) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY Back to Search Results
Model Number D-1282-08-S
Device Problems Difficult to Remove (1528); Sticking (1597); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/25/2016
Event Type  Malfunction  
Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation. The analysis has begun but is not completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. (b)(4).

 
Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia procedure with a pentaray nav eco high-density mapping catheter and the deflection became stuck. During the procedure, when the catheter was deflected, it would not relax as desired or stay in a relaxed position. This was tested by two physicians. There was difficulty in removing the catheter. There was no ring or other physical damage observed on the catheter. Replacing the catheter resolved the issue. The procedure was completed with no patient consequence.

 
Manufacturer Narrative

(b)(4) it was reported that a patient underwent an ischemic ventricular tachycardia procedure with a pentaray nav eco high-density mapping catheter and the deflection became stuck. Upon receipt, the catheter was visually inspected and it was found in normal conditions. Then per the event, a deflection test was performed and the catheter passed. Catheter was not stuck while performing the test nor was any abnormal condition observed. The device history record (dhr) was reviewed and no anomalies were found related to this complaint. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. The customer complaint cannot be confirmed.

 
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Brand NamePENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
Type of DeviceCATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
Manufacturer (Section D)
BIOSENSE WEBSTER, INC. (JUAREZ)
circuito interior norte #1820
parque industrial salvacar
juarez, chihuahua 32599
MX 32599
Manufacturer (Section G)
BIOSENSE WEBSTER, INC. (JUAREZ)
circuito interior norte #1820
parque industrial salvacar
juarez, chihuahua 32599
MX 32599
Manufacturer Contact
joaquin kurz
33 technology drive
irvine, CA 92618
9497893837
MDR Report Key5587573
MDR Text Key44154315
Report Number9673241-2016-00278
Device Sequence Number1
Product Code MTD
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123837
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device MODEL NumberD-1282-08-S
Device Catalogue NumberD128208
Device LOT Number17413248L
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/27/2016
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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