MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. DECANAV; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number R7F282CT

Device Problem Communication or Transmission Problem (2896)

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

Event Date 11/28/2018

Event Type  malfunction  

Event Description

1st: catheter pole 7-8 no signal.2nd: catheter steering mechanism not functioning properly.

• Brand Name: DECANAV
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 5110 commerce rd.; baldwin park CA 91706
• MDR Report Key: 8495424
• MDR Text Key: 141335916
• Report Number: 8495424
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 31022529M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14600 DA