MAUDE Adverse Event Report: MEDTRONIC BROCKENBROUGH TRANSSEPTAL NEEDLE (STERILE); TROCAR

Model Number UNKNOWN

Device Problem Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

During an ablation procedure, a crss polarsheath steerable sheath was selected for use.It was reported that after the brockenbrough method was performed, the left superior pulmonary vein (lspv) was ablated and when occluding the left inferior pulmonary vein (lipv) a popping sound was heard, and bending could not be maintained.Sheath was replaced with another of same model and procedure was completed successfully.No patient complications reported.Product is expected to be returned.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BROCKENBROUGH TRANSSEPTAL NEEDLE (STERILE)
• Type of Device: TROCAR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17490077
• MDR Text Key: 320697247
• Report Number: MW5122595
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN
• Patient Sequence Number: 1