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

Model Number R7F282CT

Device Problems Communication or Transmission Problem (2896); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Event Description

Electrophysiology (ep) catheter decanav is not being able to recognized by carto, the mapping system.Unable to create a matrix.The cable was replaced first, and there was still no communication.The catheter was then replaced, and the issue was resolved.There was no harm to the patient.

• Brand Name: DECANAV
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 15715 arrow hwy; irwindale CA 91706
• MDR Report Key: 10173387
• MDR Text Key: 195737618
• Report Number: 10173387
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/16/2020

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: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30341049M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Weight: 52