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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
Model Number SGC0701
Device Problems Positioning Failure (1158); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/23/2021
Event Type  malfunction  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report inability to straighten tip. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4. It was noted constricted vein. The steerable guide catheter (sgc) was inserted into the vein, but could not cross the septum due to anatomical challenges. Therefore, the sgc was removed. However, the natural curve of the sgc was observed to be bent and the sgc could no longer be straightened. The procedure continued with a new sgc. One clip was 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 Key11807745
MDR Text Key250370364
Report Number2024168-2021-03996
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190167
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 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/06/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10107U127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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