• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE INC. WOLF LUMITIP DISSECTOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRICURE INC. WOLF LUMITIP DISSECTOR Back to Search Results
Model Number MID1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Atrial Perforation (2511)
Event Date 12/12/2016
Event Type  Injury  
Manufacturer Narrative
Case (b)(4). The device was not returned for evaluation. The device history record was reviewed for non-conformance reports and reworks. There were no ncrs or re-works found that would have caused or contributed to the reported event. The complaint could not be confirmed. Discarded by facility.
 
Event Description
During total thoracoscopic cardiac ablation/ maze, surgeon was doing left sided lesions and attempted to go around pulmonary veins and nicked the back side of atrium. Procedure was prolonged as the patient had to go on-pump for a short period of time to repair atrium puncture. All lesions were complete, with the exception of left pulmonary veins. Physician did not finish left pulmonary vein isolation, based on location of atrial repair. But the laa was clipped utilizing ach 240. Patient is doing fine as this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameWOLF LUMITIP DISSECTOR
Type of DeviceLUMITIP DISSECTOR
Manufacturer (Section D)
ATRICURE INC.
7555 innovation way
mason OH 45040
Manufacturer Contact
ranjana iyer
7555 innovation way
mason, OH 45040
5137555328
MDR Report Key6231069
MDR Text Key64122263
Report Number3003502395-2016-00177
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2019
Device Model NumberMID1
Device Catalogue NumberA000195
Device Lot Number63944
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2016
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 Treatment Data
Date Received: 01/06/2017 Patient Sequence Number: 1
Treatment
ACH240
-
-