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

Model Number D728260RT

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  malfunction  

Event Description

When the catheter was connected to the cables, there were noises on the pins 5 & 6 and pins 1 & 2.The catheter was removed and a new catheter was used.No injury to the patient.This is a continuation of problems with this manufacturer's products.

• Brand Name: WEBSTER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7513746
• MDR Text Key: 108260662
• Report Number: 7513746
• 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: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: D728260RT
• Device Catalogue Number: D728260RT
• Device Lot Number: 30015090M
• 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: 05/09/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR