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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 Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The clip delivery system referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report the loss of fluid column in the sgc. It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr). This was a straightforward case. The first mitraclip was implanted, but right after clip deployment, the anterior leaflet came out of the deployed clip, resulting in a single leaflet device attachment. After the clip delivery system (cds) was removed from the steerable guide catheter (sgc), the sgc hemostatic valve was noted to have a loss of fluid column as air was being aspirated after cds removal per the standard practice. The physician placed his finger over the sgc hemostatic valve, which held fluid column until the sgc was able to be removed from the patient. No air had entered the patient anatomy. A new sgc was prepared and inserted. A second mitraclip was implanted which stabilized the first clip and reduced mr. The procedure was completed with mr grade 1. There were no adverse patient effects and no clinically significant delay in the procedure. There was no additional information 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 Key10751882
MDR Text Key213659299
Report Number2024168-2020-09006
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 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/27/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00728U118
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 Received11/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2020
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: 10/28/2020 Patient Sequence Number: 1
Treatment
MITRACLIP CLIP DELIVERY SYSTEM
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