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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR SGC03 VALVE REPAIR

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ABBOTT VASCULAR SGC03 VALVE REPAIR Back to Search Results
Model Number SGC0301
Device Problem Leak/Splash (1354)
Patient Problems Air Embolism (1697); Bradycardia (1751)
Event Date 03/17/2020
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. Na.
 
Event Description
This is filed to report a leak and air embolism. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc) 91221u160 was inserted, but air started to appear in the column. Aspiration was performed, but the air was still present. It was noted that some air may have entered the patient, causing bradycardia. To treat the bradycardia, medication was given, which returned the patient heart rate to a normal sinus rhythm. The sgc was removed and was attempted to be re-prepped; however, a loss of fluid column occurred. The device was not used and was replaced. One clip was successfully implanted, reducing mr to a grade of 2. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameSGC03
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9920945
MDR Text Key186717860
Report Number2024168-2020-03331
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/20/2020
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number91121U160
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/03/2020 Patient Sequence Number: 1
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