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

Model Number 85784

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the procedure, the engineer cut their hand on a damaged irrigation pump.It was noted that before transportation to the hospital, the device was damaged.Despite the damage, the device was used during the procedure and the procedure was able to be completed with no adverse consequences.No intervention was needed to address the injury.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: COOL POINT IRRIGATION PUMP
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• MDR Report Key: 11250584
• MDR Text Key: 229313884
• Report Number: 2030404-2021-00002
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85784
• Device Lot Number: 6009135
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other