MAUDE Adverse Event Report: UNKNOWN BROCKENBROUGH; TROCAR

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

During an ablation procedure, a crbs 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
• Type of Device: TROCAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17414742
• MDR Text Key: 320112616
• Report Number: MW5120275
• 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: Other
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention