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

Model Number D128211

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2018

Event Type  malfunction  

Event Description

Penta-ray catheter created a sensor error upon using.Catheter malfunction.No harm to patient.Catheter sent to biosense for review.Catheter is not available for return.It was sent to biosense.Unable to confirm how it was sent.No harm to patient.

• 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 Key: 8068638
• MDR Text Key: 127117557
• Report Number: 8068638
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 17757561L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA