MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT EXCALIBUR BALLOON CATHETER

Model Number	18-4000-27A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no additional information for this adverse event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Transseptal access was done and lspv was isolated.During lipv isolation patient blood pressure decreased and pericardial effusion was noted.No deficiencies with any cardiofocus device were reported.
Additional Manufacturer Narrative
The device serial # and lot # have been corrected.There is no additional information for this adverse event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Transseptal access was done and lspv was isolated.During lipv isolation patient blood pressure decreased and pericardial effusion was noted.No deficiencies with any cardiofocus device were reported.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT EXCALIBUR BALLOON CATHETER
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 7886549
• Report Number: 1225698-2018-00012
• Device Sequence Number: 16626272
• Product Code: OAE
• UDI-Device Identifier: 00868976000178
• UDI-Public: 00868976000178
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150026/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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: 05/31/2019
• Device Model Number: 18-4000-27A
• Device Catalogue Number: 18-4000-27A
• Device Lot Number: 10463-26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: 75 YR