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)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency was reported.Pseudoaneurysm is a known potential adverse event documented in product labeling.It cannot be determined if there was any relationship between the pseudoaneurysm and the introducer sheath, but it cannot be conclusively ruled out so this mdr is being reported.
Event or Problem Description
After a successful pulmonary vein isolation (pvi) ablation procedure to treat atrial fibrillation, tenderness in right groin area was reported the morning after the procedure.Arterial duplex doppler revealed a 3 cm pseudoaneurysm arising from the right common femoral artery.Interventional radiology was used to inject heparin and hospitalization was extended by one day.The patient status is being monitored.

• 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: 11555957
• Report Number: 1225698-2021-00004
• Device Sequence Number: 4049296
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K152310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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: 07/31/2021
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: Q1507168
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/23/2021
• 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; Other
• Patient Age: 64 YR
• Patient Weight: 147