MAUDE Adverse Event Report: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION SUPREME; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 401890

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Event Description

Quad catheter not visible on carto.Flickering.Inserted in body, removed intact.No patient harm.

• Brand Name: SUPREME
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL CARDIOVASCULAR DIVISION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 16013561
• MDR Text Key: 305796160
• Report Number: 16013561
• 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: 12/14/2022

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: 401890
• Device Catalogue Number: 401890
• Device Lot Number: 8551047
• 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: 12/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: White