MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK; TROCAR

Device Problem Unintended Movement (3026)

Patient Problem Pericardial Effusion (3271)

Event Date 08/28/2018

Event Type  Injury  

Event Description

It was reported that the patient developed tamponade during a vt procedure.As the physician performed the transseptal procedure he remarked on how high it was and performed a second transseptal puncture.When they observed intracardiac echo a very large effusion was noted.A pericardiocentesis was performed, removing 1600 ml of fluid from around the heart, the blood was transfused back into the patient.The patient was stable at the time of the call.There was no detectable decrease in patient blood pressure.Bwi mapping catheter in use (no ablation was performed): (b)(4)/30064153l.Mapping only was performed in the left ventricle and epicardial space.The physician believed the complication occurred as a result of one of the transseptal punctures.Non-bwi equipment was used for transseptal.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BRK
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17532363
• MDR Text Key: 321061421
• Report Number: MW5139271
• Device Sequence Number: 1
• Product Code: DRC
• 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: 09/26/2018

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
• Treatment: TERUMO 7,8,11 FR SHEATH.