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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER
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ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Catalog Number UNK AMPLATZER OCCLUDER
Device Problems No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
It was reported that on an unknown date, an unknown size device was implanted in the patient using an unknown delivery system.On 45 day follow up transesophageal echocardiogram (tee) reveled a clot on the disc.
 
Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Manufacturer Narrative
Correction: upon review, the amplatzer septal occluder should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction and/or a serious injury.D4 - the udi number is not known as the part and lot numbers were not provided.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information correction: upon review, the amplatzer septal occluder should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction and/or a serious injury.H6 health effect - impact code 4614 was removed.H6 medical device problem codes 4001 was removed.
 
Event Description
It was reported that on an unknown date, an unknown size device was implanted in the patient using an unknown delivery system.On 45 day follow up transesophageal echocardiogram (tee) reveled a clot on the disc.
 
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Brand Name
AMPLATZER SEPTAL OCCLUDER
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
ABBOTT MEDICAL REG# 2135147
5050 nathan ln n
plymouth MN 55442
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key18446539
MDR Text Key332143095
Report Number2135147-2024-00067
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK AMPLATZER OCCLUDER
Is the Reporter a Health Professional? No
Date Manufacturer Received01/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Other;
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