MAUDE Adverse Event Report: ST. JUDE MEDICAL TROCAR

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2015

Event Type  Injury  

Event Description

Adverse event during a procedure.Puncture to the heart.Procedure not completed.This was not caused by a j and j product.A (b)(6) needle was responsible.(b)(6) sl0 sheath also used.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TROCAR
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17529315
• MDR Text Key: 321131097
• Report Number: MW5136243
• 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: 09/09/2015

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