MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIPP LAA EXCLUSION SYSTEM

Model Number ACH140

Device Problem Fungus in Device Environment (2316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4): device not returned for evaluation however device history record reviewed and no non-conformance or rework noted during manufacturing process that would be related to the reported issue.

Event Description

It was reported by the customer during a aortic root replacement with prosthetic valve, maze procedure with left atrial appendage exclusion.The pt presented (b)(6) post-op with "black mold" endocarditis, black mold sternal wound and black mold present on all implants.The procedure involved several devices from different medical device manufacturers.The facility was uncertain as to where the infection original or its cause.

• Brand Name: ATRICLIPP LAA EXCLUSION SYSTEM
• Type of Device: ATRICLIPP LAA EXCLUSION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; west chester OH
• Manufacturer Contact: john huff ; 6217 centre park drive; west chester, OH 45069 ; 5136444725
• MDR Report Key: 5003416
• MDR Text Key: 23191120
• Report Number: 3003502395-2015-00029
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Not Applicable
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Model Number: ACH140
• Device Catalogue Number: A000689
• Device Lot Number: 55869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 46 YR
• Patient Weight: 136