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

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).

• Brand Name: CARTO PENTARAY ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. ; irvine CA 92618
• MDR Report Key: 8627736
• MDR Text Key: 145780598
• Report Number: MW5086781
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 05/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D128208
• Device Lot Number: 30175450L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 56 YR
• Patient Weight: 55