Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  • 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
 

MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number 990063-020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Pneumonia (2011); Pulmonary Edema (2020); Pulmonary Valve Stenosis (2024); Heart Failure (2206); Stenosis (2263); Respiratory Failure (2484); Low Cardiac Output (2501)
Event Date 05/09/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that following a successful cryo ablation procedure, the patient had an acute onset of shortness of breath and a cough.The patient became hypoxic and went to the emergency room, where he was found to have bilateral pulmonary edema.A left heart catheterization was performed, and abnormal 80% stenosis extending into the left anterior descending artery was noted.A chest x-ray showed abnormal stable patchy airspace disease.A carotid arterial duplex showed abnormal 50% stenosis.Intravenous, oral and intramuscular medication was administered.The patient was hospitalized for a prolonged period.The patient's outcome is unresolved.No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient is a participant in a clinical study.
 
Event Description
It was reported the adverse event resolved.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
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.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
Incoming information noted that the patient was diagnosed with coronary artery disease, acute respiratory failure, hypertension, hypoxemia, and syncope.The patient had a coronary bypass procedure five days post-cryoablation.
 
Manufacturer Narrative
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
Additional information indicates the patient had a right heart catheterization.The coronary artery disease was noted to extend into the circumflex.Mildly abnormal right heart pressures at rest were noted.'normal cardiac' was indicated.Cardiomyopathy with a depressed left ventricular ejection fraction was noted, as well as acute respiratory failure secondary to either heart failure or pneumonia.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACHIEVE MAPPING CATHETER - 20 MM
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
MDR Report Key10085730
MDR Text Key192145206
Report Number9612164-2020-01966
Device Sequence Number1
Product Code DRF
UDI-Device Identifier00643169467385
UDI-Public00643169467385
Combination Product (y/n)N
PMA/PMN Number
K102588
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/24/2022
Device Model Number990063-020
Device Catalogue Number990063-020
Device Lot Number219290886
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/13/2020
Initial Date FDA Received05/25/2020
Supplement Dates Manufacturer Received05/13/2020
07/01/2020
07/01/2020
07/31/2020
Supplement Dates FDA Received06/01/2020
07/02/2020
07/23/2020
08/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
2AF284 BALLOON CATHETER, 4FC12 SHEATH.
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age76 YR
Patient Weight68
-
-