MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. BIOSENSE WEBSTER PENTARAY NAV ; CATHETER, INTRACARDIAL MAPPING HIGH DENSITY ARRAY

Catalog Number D128211

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2019

Event Type  malfunction  

Event Description

During ep cryo-ablation case, 3d map of biosense webster pentaray catheter was no longer visible and usable.Physician tried to replace pentaray cath to rebuild 3d map but to no avail.Case had to be abandoned without successful intervention.Physician reported he has encountered such intermittent issues in the past with the pentaray catheter.Fda safety report id# (b)(4).

• Brand Name: BIOSENSE WEBSTER PENTARAY NAV
• Type of Device: CATHETER, INTRACARDIAL MAPPING HIGH DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. ; irwindale CA
• MDR Report Key: 9601537
• MDR Text Key: 176020108
• Report Number: MW5092335
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D128211
• Was Device Available for Evaluation?: No
• 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): Other
• Patient Age: 66 YR