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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE

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ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE Back to Search Results
Catalog Number SGC0702
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)
Event Date 07/27/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The investigation was unable to determine a cause for the reported unspecified tissue injury and thrombosis. Unspecified tissue injury and thrombosis are listed in the instructions for use as known possible complications associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design, or labeling.
 
Event Description
This is filed to report thrombus and tissue damage. 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) was advancing towards the left atrium when a structure was observed near the sgc. The structure is suspected to be thrombus or possible tissue damage. The activated clotting time (act) was approximately 300 at this time. After a couple of minutes, the structure was no longer visible. The procedure continued and the same sgc was advanced to the mitral valve, and the clip was deployed. Three clips were implanted, reducing mr to 1-2. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameG4 STEERABLE GUIDING CATHETER
Type of DeviceCATHETER, STEERABLE
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 Key12308207
MDR Text Key266042976
Report Number2024168-2021-07074
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/22/2022
Device Catalogue NumberSGC0702
Device Lot Number10223U153
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 Received07/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2021
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: 08/11/2021 Patient Sequence Number: 1
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