MAUDE Adverse Event Report: ST. JUDE MEDICAL CATHETER, PERCUTANEOUS CARDIAC ABLATION; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/14/2015

Event Type  Injury  

Event Description

It was reported that at the end of a complex procedure on (b)(6) 2015, the patient was noted to have a "pericardial" effusion/tamponade while the physician user was evaluating the cardiac silhouette on fluoroscopy.The effusion was confirmed with uls/ice.A pericardiocentesis was performed and the patient stabilized.Other bwi products in use: c3 sn: (b)(6), stockert (sn unknown), coolflow pump (sn unknown), a bwi lasso (catalog and lot# unknown).All catheters and packaging were discarded during the intervention.Lot# for the st catheter is also unknown.Iv fluids and additional medications provided by anesthesiologist, amounts types are not known.A bwi product is not believed to be responsible for the injury.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERCUTANEOUS CARDIAC ABLATION
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17530134
• MDR Text Key: 321092063
• Report Number: MW5137054
• Device Sequence Number: 1
• Product Code: OAD
• 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: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1