MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK 1 NEEDLE; TROCAR

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Date 02/16/2015

Event Type  Injury  

Event Description

This letter is to inform you of this adverse event as the suspect devices (st.Jude - brk 1 needle/ 8.5 sheath sl1 18) are not manufactured or imported by biosense webster, inc.It was reported by the caller that during the transseptal puncture for an afib procedure the patient developed a pericardial effusion.A pericardiocentesis was performed in which 300cc's was removed from the pericardial space.The patient was stabilized and transferred to the ccu for observation.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BRK 1 NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17526846
• MDR Text Key: 321066461
• Report Number: MW5133783
• 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: 03/17/2015

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
• Treatment: ST. JUDE 8.5 SHEATH SL1 18 INTRODUCER