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

Model Number D128208

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 09/25/2018

Event Type  malfunction  

Event Description

A catheter sensor error came across during an ablation case.The cable was switched out but no resolution so another catheter was used and worked fine.

• 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: 7960121
• MDR Text Key: 123556353
• Report Number: 7960121
• 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: 10/02/2018,09/26/2018

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 Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30078030L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1