MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. COOL POINT ¿ IRRIGATION PUMP; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 85784

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Event Description

During device preparation for an a typical flutter procedure, the pump started smoking shortly after being turned on.The pump was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

The pump met specifications during flow test and the extra running time, no errors or other functional anomalies were noted.No smoking was observed during the entire running time.The device met specifications prior to release from abbott manufacturing facilities as supported by the device history record.The cause of the reported smoking remains unknown.

• Brand Name: COOL POINT ¿ IRRIGATION PUMP
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 7773091
• MDR Text Key: 117283930
• Report Number: 2030404-2018-00059
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P060019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85784
• Device Lot Number: 5384646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1