MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER

Model Number	18-2531-N250
Medical Device Problem Codes	Energy Output Problem (1431); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned catheter found damage to the nosecone of the lesion generator.This damage allowed liquid to enter the nosecone, which is a space normally filled with air, possibly resulting in energy being directed in a location other than the intended location and which is visible to the user by a change in aiming beam appearance.The instructions for use (ifu) directs the user to replace the device if the aiming beam intensity is reduced or appears distorted.The user noticed the decrease in aiming beam appearance but did not replace the device until after treating an additional pulmonary vein.The damage to the nosecone appeared to have been caused during use of the device, which can occur if the ifu cautions for device handling are not followed.This complaint is similar to a previously filed mdr involving a serious injury (mdr 1225698-2018-00015 supplement).In the previously filed mdr, it could not be determined if there was a relationship between the product malfunction and the adverse event.In the case of this report, there was no adverse event.21 cfr 803.50(2) requires the reporting of a complaint as an mdr if the device: has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.Damage to the nosecone resulting in a distorted aiming beam is visible to the user, and replacement of the device ensures there is no risk of harm.Because the device was not replaced after the aiming beam was noted to be abnormal, it cannot be determined if it is likely this event would have caused or contributed to a death or serious injury, but it cannot be excluded.Because this event is similar to a previously reported mdr, it is being reported as an mdr.
Event or Problem Description
During an independent procedure with no company representatives present the user noted the aiming beam was smaller than usual but continued to use the device.During continued use of the device the aiming beam then appeared scattered at which point the device was replaced.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT CATHETER
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro, ma
• MDR Report Key: 10258802
• Report Number: 1225698-2020-00020
• Device Sequence Number: 19483704
• 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): 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 18-2531-N250
• Device Catalogue Number: 18-2531-N250
• Device Lot Number: 12388-010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1