MAUDE Adverse Event Report: STERILMED, INC. COURNAND; CATHETER, ELECTRODE RECORDING

Catalog Number 401860

Device Problems Signal Artifact/Noise (1036); Device Operates Differently Than Expected (2913)

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

Event Date 07/09/2015

Event Type  malfunction  

Event Description

The reprocessed catheter was placed in the body for internal electrocardiogram tracings, and the monitor displayed a tremendous amount of artifact.So much so that internal tracings could not be seen.Removed from the patient and used another catheter which provided a clear tracing.

• Brand Name: COURNAND
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd avenue north; ste 100; maple grove MN 55369
• MDR Report Key: 4942133
• MDR Text Key: 20774669
• Report Number: 4942133
• Device Sequence Number: 1
• Product Code: DRF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/16/2015

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: Physician
• Device Catalogue Number: 401860
• Device Lot Number: 1829006
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 54 YR