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

Model Number R7F282CT

Device Problems Bent (1059); Connection Problem (2900)

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

Event Date 05/30/2017

Event Type  malfunction  

Event Description

When the catheter was inserted, there was a difficulty connecting to the cable.Trouble shooting found that the pins in the catheter side were bent and unable to fix.The catheter was removed and a new catheter was used.No injury 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: 6656716
• MDR Text Key: 78062037
• Report Number: 6656716
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 17655582M
• 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: 06/14/2017
• Event Location: Other
• Date Report to Manufacturer: 06/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR