ACQMAP? 3D IMAGING AND MAPPING CATHETER 900003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-16 for ACQMAP? 3D IMAGING AND MAPPING CATHETER 900003 manufactured by Acutus Medical, Inc..

MAUDE Entry Details

• Report Number: 3012120746-2020-00002
• MDR Report Key: 9597904
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2020-01-16
• Date of Event: 2019-12-17
• Date Mfgr Received: 2019-12-17
• Device Manufacturer Date: 2019-05-15
• Date Added to Maude: 2020-01-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. KAREN KINCADE
• Manufacturer Street: 2210 FARADAY AVENUE SUITE 100
• Manufacturer City: CARLSBAD CA 92008
• Manufacturer Country: US
• Manufacturer Postal: 92008
• Manufacturer Phone: 4422326123
• Manufacturer G1: ACUTUS MEDICAL
• Manufacturer Street: 2210 FARADAY AVENUE SUITE 100
• Manufacturer City: CARLSBAD CA 92008
• Manufacturer Country: US
• Manufacturer Postal Code: 92008
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ACQMAP? 3D IMAGING AND MAPPING CATHETER
• Generic Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Product Code: MTD
• Date Received: 2020-01-16
• Model Number: 900003
• Catalog Number: 900003
• Lot Number: 10288
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ACUTUS MEDICAL, INC.
• Manufacturer Address: 2210 FARADAY AVENUE SUITE 100 CARLSBAD CA 92008 US 92008

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2020-01-16