FDA Adverse Event Malfunction Summary report: N

HEARTFLOW ANALYSIS

MDR report key: 20242151 · Received September 17, 2024

Report

Report Number: 3021637148-2024-00010
Event Type: Malfunction
Date Received: September 17, 2024
Date of Event: July 17, 2024
Report Date: September 17, 2024
Manufacturer: HEARTFLOW, INC.
Product Code: PJA
UDI-DI: 00853341006060
PMA / PMN Number: K213857
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

AS PART OF HEARTFLOW'S INTERNAL REVIEW, WE IDENTIFIED AN OVERSIZED MODELING OF THE LEFT MAIN ARTERY IN THE HEARTFLOW ANALYSIS. HFID# (B)(4): THE INVESTIGATION DETERMINED THAT THE LEFT MAIN WAS MODELED LARGER THAN WHAT IS INDICATED IN THE CT DATA DUE TO MISINTERPRETATION BY HEARTFLOW'S AUTOMATED TECHNOLOGY AND INSPECTION PROCESS. THE CENTERLINE PLACEMENT WAS NOT CENTERED IN THE LUMEN IN ERROR. HEARTFLOW HAS NOTIFIED THE CUSTOMER OF THE INVESTIGATION RESULTS. THE PHYSICIAN HAS NOT REPORTED A SAFETY EVENT WITH THE PATIENT AT THIS TIME. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE. HEARTFLOW'S ANALYSIS INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNINGS: DUE TO THE VARIABILITY IN THE HEARTFLOW ANALYSIS, THE FFRCT VALUES SHOULD BE REVIEWED AS ONE OF SEVERAL CLINICAL DATA POINTS TO BE USED IN CONJUNCTION WITH THE PATIENT'S ORIGINAL CT IMAGES, CLINICAL HISTORY, SYMPTOMS, AND OTHER DIAGNOSTIC TESTS, AS WELL AS AN APPROPRIATELY TRAINED CLINICIAN'S CLINICAL JUDGMENT, TO EVALUATE THE PATIENT.

Description of Event or Problem · 0

HEARTFLOW IDENTIFIED POTENTIAL OVERSIZED MODELING OF THE LEFT MAIN ARTERY IN THE HEARTFLOW ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2527215	HEARTFLOW ANALYSIS	HEARTFLOW ANALYSIS	PJA	HEARTFLOW, INC.	3.32.2.2		00853341006060

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other