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	Hematoma (1884)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This adverse event was one of three reported in an advance publication and was not reported directly to the manufacturer.A request for additional information has been made and limited patient information received.There was no device deficiency reported.The publication is circulation journal, doi: 10.1253/circj.Cj-19-0766.The physician reported the adverse event was not directly related to the device.However, causality could not be established so the event is being reported.Vascular damage is a known potential adverse event of catheter ablation procedures.
Event or Problem Description
An advance literature publication reported a vascular access complication in a pulmonary vein isolation (pvi) procedure.The patient developed a severe groin hematoma, which was treated by blood transfusion.No surgical intervention was necessary.No product information was provided and no device deficiency reported.The vascular access complication was reported as not directly related to the manufacturer's device.

• 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: 9434434
• Report Number: 1225698-2019-00040
• Device Sequence Number: 2158502
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/06/2019

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 Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/06/2019
• 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: Other
• Patient Age: 68 YR