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

Model Number ST. JUDE MEDICAL/ ABBOTT BRK-1 TRANSSEPTAL NEEDLE; ST. JUDE MEDICAL/ABBOTT SWAR

Device Problem Unintended Movement (3026)

Patient Problem Pericardial Effusion (3271)

Event Date 01/29/2018

Event Type  Injury  

Event Description

It was reported that during an afib case, a pericardiai effusion was noticed.Caller reported that the mapping catheter was inserted into what was thought to be the left atrium but was actually the pericardium.The pericardiai effusion was confirmed by ice to see if the heart had the effusion.Also confirmed by a transthoracic echo.Caller reported that the medical intervention provided was a pericardiocentesis and 1900 ml of fluid was removed.The patient was reported to be in stable condition and was currently in life flight heading to the hospital.Additional information received stated that it was the physician's opinion that the effusion was caused by a bad location for transeptal puncture.Transseptal puncture was performed with a st.Jude medical/abbott brk-1 transseptal needle and st.Jude medical/abbott swartz 71 cm sl1 sheath.(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: 17523064
• MDR Text Key: 321061598
• Report Number: MW5130012
• 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: 02/16/2018

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
• Device Model Number: ST. JUDE MEDICAL/ ABBOTT BRK-1 TRANSSEPTAL NEEDLE; ST. JUDE MEDICAL/ABBOTT SWAR
• Patient Sequence Number: 1
• Treatment: ST JUDE SWARTZ SHEATH