MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE SHEATH

Model Number	18-3356
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: HEARTLIGHT DEFLECTABLE SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 9330856
• Report Number: 1225698-2019-00034
• Device Sequence Number: 2616022
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization