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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

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MEDTRONIC, INC. CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number 106A3
Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2023
Event Type  Injury  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The received failure file contained failure records for the date of the event.The failure file showed system notice 50002 (the system has detected an electrical component failure) on the reported date of the event.The returned patient file showed test applications performed using non-clinical catheters.The product issue reported (system notice 50002 and lpr) is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.In conclusion, the physical console was not returned and aborted under general anesthesia cannot be assessed through data analysis.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
It was reported that during a cryo ablation procedure, the low pressure regulator (lpr) was higher than expected.The console was vented five times without resolve.A number of ablations were carried out and the low pressure regulator (lpr) came back into range.The case was aborted, the patient was under general anesthesia.  test injections were carried out and a system notice was received indicating that the system detected an electrical component failure.No patient complications have been reported as a result of this event.
 
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Brand Name
CRYOCONSOLE
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key17994747
MDR Text Key326365954
Report Number2182208-2023-03174
Device Sequence Number1
Product Code LPB
UDI-Device Identifier00763000011147
UDI-Public00763000011147
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P020045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 10/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number106A3
Device Catalogue Number106A3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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