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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
Catalog Number SGC0302
Device Problems Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
Revised. It was reported that the mitraclip procedure was performed to treat mixed mitral regurgitation with grade of 4. The patient had a small anatomy with small atrium, the septal puncture was a huge problem and the height over the valve was 3. 3 cm. The steerable guide catheter (sgc) was inserted and advanced into artery, per the instruction for use (ifu). The physician had to manipulate the clip delivery system (cds) to gain height to the mitral valve; therefore, more curves were applied to the cds than usual and tension was very high. Before clip deployment, the gripper line broke as due to too much tension. The procedure was aborted as the second cds would have the same issue. The cds with the clip attached and gripper line were removed. There were no clips implanted, mr remained at 4. There was no adverse patient effect and no clinically significant delay in the procedure. The cds was returned inside the sgc and analysis revealed that the sgc soft tip was torn. 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 Key9823793
MDR Text Key183125977
Report Number2024168-2020-02314
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2019
Device Catalogue NumberSGC0302
Device Lot Number81114U124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/12/2020 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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