MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER

Model Number	18-2531-N250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	04/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency was reported.Cardiac tamponade is a known potential adverse event documented in product labeling.
Event or Problem Description
A pulmonary vein isolation procedure (pvi) to treat atrial fibrillation was performed with all veins treated with the heartlight catheter.During touch up ablation with a radiofrequency (rf) catheter after all veins had been treated, cardiac tamponade was diagnosed by decrease in blood pressure.The drop in blood pressure was reported to have started approximately 10-15 minutes after ablation with the rf catheter began, although the exact time was not recorded.Pericardial drainage was performed to treat the tamponade.In addition to the rf catheter, a ring electrode catheter was used prior to the heartlight catheter during the procedure for four of the pulmonary vein treatments.Because of restrictions due to the coronavirus on hospitals in (b)(6), no further information could be obtained regarding this event.This mdr is being filed because it cannot definitely be determined what device or devices lead to the cardiac tamponade.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT CATHETER
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro, ma
• MDR Report Key: 10017544
• Report Number: 1225698-2020-00014
• Device Sequence Number: 3303716
• Product Code: OAE
• UDI-Device Identifier: 00868976000109
• UDI-Public: 00868976000109
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150026
• 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): 05/01/2020

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: 02/28/2021
• Device Model Number: 18-2531-N250
• Device Catalogue Number: 18-2531-N250
• Device Lot Number: 12160-004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 05/01/2020
• 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: 78 YR