• 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. CARTO PENTARAY ECO CATHETER 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. CARTO PENTARAY ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY Back to Search Results
Catalog Number D128208
Device Problems Material Fragmentation (1261); Difficult to Remove (1528)
Patient Problems Mitral Regurgitation (1964); Device Embedded In Tissue or Plaque (3165)
Event Date 04/30/2019
Event Type  Injury  
Event Description

Pt has a significant history that included mechanical mitral valve. Pt underwent cardiac ep atrial flutter ablation with the biosense pentaray catheter. During the procedure two of the catheter's splines became stuck in the mechanical valve and were unable to be retrieved. The pt was listed for emergent heart transplant post-procedure and was transplanted on (b)(6) 2019. The pt is currently stable and improving back to baseline health; plan for discharge home next week. The echocardiogram suggested that one of the leaflets of the mechanical mitral valve may be in a fixed position and not moving. The study suggested mild prosthetic mitral regurgitation. The right heart catheterization suggested two catheter fragments entrapped within the mechanical mitral valve with the involved leaflet in a closed position, the second leaflet was moving freely. A swan-ganz catheter was also placed during this procedure. Fda safety report id# (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARTO PENTARAY ECO CATHETER
Type of DeviceCATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
Manufacturer (Section D)
BIOSENSE WEBSTER, INC.
irvine CA 92618
MDR Report Key8627736
MDR Text Key145780598
Report NumberMW5086781
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 Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 05/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberD128208
Device LOT Number30175450L
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/30/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/20/2019 Patient Sequence Number: 1
-
-