MAUDE Adverse Event Report: ABBOTT / ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. XS BRK NEEDLE; TROCAR

Model Number ABBOTT 98CM XS BKR NEEDLE

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that during an irreversible electroporation ablation procedure using a sheath they temporarily loss left atrium access.The sheath was used for the transseptal puncture.When removing the dilator from the sheath a lot of force was required to remove the dilator which resulted in the loss of access.The procedure was completed using the original device with no patient complications.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Reference report mw5148841.

• Brand Name: XS BRK NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ABBOTT / ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.
• MDR Report Key: 18274166
• MDR Text Key: 330002190
• Report Number: MW5148840
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/19/2023

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?: Yes
• Device Model Number: ABBOTT 98CM XS BKR NEEDLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2023
• Patient Sequence Number: 1