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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT

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MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT Back to Search Results
Model Number 990063-020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pericardial Effusion (3271)
Event Date 03/11/2024
Event Type  Injury  
Event Description
It was reported that during a cryo ablation procedure, the mapping catheter was advanced into the right superior pulmonary vein (rspv), but under fluoroscopy, it seemed the mapping catheter was not in the rspv.An echocardiography revealed a pericardial effusion.Pericardial drainage was performed and the procedure was aborted when the effusion was no longer observed.No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
ACHIEVE MAPPING CATHETER - 20 MM
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
Manufacturer (Section D)
MEDTRONIC MEXICO S. DE R.L. DE CV
av. paseo del cucapah #10510
tijuana,bc 22210
MX  22210
Manufacturer (Section G)
MEDTRONIC MEXICO S. DE R.L. DE CV
av. paseo del cucapah #10510
tijuana,bc 22210
MX   22210
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key18962034
MDR Text Key338388162
Report Number3002648230-2024-00105
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K102588
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/22/2024
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 Model Number990063-020
Device Catalogue Number990063-020
Device Lot Number227846028
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received03/22/2024
Date Device Manufactured11/29/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SEE H11...
Patient Outcome(s) Required Intervention;
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