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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS CARDIOBLATE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
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PERFUSION SYSTEMS CARDIOBLATE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE Back to Search Results
Model Number 49260
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Myocardial Infarction (1969); Embolism/Embolus (4438)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information through a post market clinical follow-up (pmcf) survey that following use of the cardioblate gemini-x surgical ablation device at an unspecified time the patients experienced the following; postoperative embolic complications and acute ischemic myocardial event.The customer stated that these adverse effects were directly related to device itself and required further medical or surgical intervention.
 
Event Description
Medtronic received information through a post market clinical follow-up (pmcf) survey that following use of the cardioblate gemini legacy device, at an unspecified time the patient experienced the following; postoperative embolic complications and acute ischemic myocardial event.The customer stated that these adverse effects were directly related to device itself and required further medical or surgical intervention.
 
Manufacturer Narrative
Medtronic investigation: medtronic is unable to confirm nor deny the complaint as the device was not returned for assessment.There was no device lot number provided, so manufacturing records could not be reviewed.This investigation was completed with the information that was provided.If further information is supplied for this event, the investigation will be reopened and information documented.Medtronic will continue to monitor for future events.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information through a post market clinical follow-up (pmcf) survey that following use of the cardioblate gemini legacy device, at an unspecified time the patient experienced the following; postoperative embolic complications and acute ischemic myocardial event.The customer stated that these adverse effects were directly related to device itself and required further medical or surgical intervention.
 
Manufacturer Narrative
Additional information was received indicating that the model number used was 49260 rather than 49261.All associated fields have been updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
CARDIOBLATE
Type of Device
SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
MDR Report Key10568107
MDR Text Key207972310
Report Number2184009-2020-00054
Device Sequence Number1
Product Code OCL
Combination Product (y/n)N
PMA/PMN Number
K121767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial,Followup,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number49260
Device Catalogue Number49260
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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