MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE SHEATH

Model Number 18-3356

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

No device deficiency was reported.Pseudo-aneurysm is a known adverse potential adverse event documented in product labeling.No adverse events related to the pvi procedure were reported peri-procedurally.

Event Description

A pulmonary vein isolation (pvi) procedure to treat atrial fibrillation was performed on (b)(6) 2018.During 3-month postoperative follow-up it was learned the patient had received an operation to treat a thrombotic venous aneurysm and the patient had already recovered.Date of onset of the adverse event was not reported.The operation to treat the thrombotic venous aneurysm was not performed by the physician performing the 3-month postoperative follow-up and details of the operation, medical condition, or treatment performed are unknown.It was reported the site of the injury was related to the puncture site of the pvi procedure, although the side of the patient with the injury was not reported so causality with the deflectable sheath cannot be determined.

• Brand Name: HEARTLIGHT
• Type of Device: HEARTLIGHT DEFLECTABLE SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• Manufacturer Contact: ian christianson ; 500 nickerson rd.; suite 500-200; marlboro, MA 01752 ; 5086587231
• MDR Report Key: 9330856
• MDR Text Key: 166935589
• Report Number: 1225698-2019-00034
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2019
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: Q1229711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization