Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. PENTARAY NAV; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOSENSE WEBSTER INC. PENTARAY NAV; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY Back to Search Results
Model Number D128208 AND D128211
Device Problems Signal Artifact/Noise (1036); Break (1069); Device Sensing Problem (2917); Electromagnetic Compatibility Problem (2927); Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 01/14/2020
Event Type  malfunction  
Event Description
We are reporting a total of 41 events with different models of electrophysiological ablation catheters by biosense webster, which occurred in the past year.In this report, we have listed 08 event out of the 41 events.The details are below: brand name: pentaray nav.Model/catalog #: d128211, lot number: 30298484l, malfunction: pole a sensor error.D128211, 30424196l, noisy signals, d128208, 30312444l, multiple sensor error, d128208, 30325380l, map sensor error, d128208, 30328751l, sensor error 116, d128208, 30337024l, bent splines, d128208, 30361789l, noise and magnetic distortion error, d128208, 30421671l, broken sensor.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11258061
MDR Text Key229596169
Report Number11258061
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 01/13/2021
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 AND D128211
Device Catalogue NumberD128208 AND D128211
Device Lot NumberSEE INFO LISTED UNDER EVENT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/13/2021
Event Location Hospital
Date Report to Manufacturer02/01/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-