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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 Problems Bronchitis (1752); Fistula (1862); Respiratory Tract Infection (2420); Hematuria (2558); Pericardial Effusion (3271)
Event Date 06/19/2023
Event Type  Injury  
Event Description
Literature was reviewed regarding left atrial appendage (laa) and cryoballoon pulmonary vein isolation (pvi).The authors described patients who experienced fourteen peri-procedural complications which included transient phrenic nerve palsies, and nine post-procedural complications which included pericardial effusions which were treated conservatively, puncture site hematomas, fistula, bronchitis, respiratory tract infection, gross hematuria, and puncture site oozing.The status of the catheters and sheaths is unknown.No additional adverse patient effects were reported.
 
Manufacturer Narrative
This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/65 years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: left atrial appendage volume is an independent predictor of atrial arrhythmia recurrence following cryoballoon p ulmonary vein isolation in persistent atrial fibrillation.Frontiers in cardiovascular medicine.2023.10:1190860.Doi: 10.3389/fcvm.2023.1190860.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 Key19098606
MDR Text Key340047660
Report Number9617601-2024-00055
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K102588
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation Physician
Type of Report Initial
Report Date 04/12/2024
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/12/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient SexMale
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