MAUDE Adverse Event Report: ABBOTT ST JUDE MEDICAL; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Device Problem Material Perforation (2205)

Patient Problem Pericardial Effusion (3271)

Event Date 08/09/2018

Event Type  Injury  

Event Description

It was reported that during a left-sided pvc ablation the patient developed a pericardial effusion.The effusion was discovered using intracardiac echo and a pericardiocentesis was immediately performed.There was no patient hypotension reported, the patient remained stable and a temporary drain was left in place.Most of the ablations were performed at the posteromedial papillary muscle, 30 watts and 8ml/min were the parameters with the stsf catheters.The physician believes that the ibi decapolar catheter in the cs may have perforated the cs orla branch of the cas, and that the ablation catheter was not believed to be the cause of the perforation.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ST JUDE MEDICAL
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 17528067
• MDR Text Key: 321045250
• Report Number: MW5134998
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1