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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 Leak/Splash (1354)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 05/17/2022
Event Type  Injury  
Manufacturer Narrative
The additional device referenced in b5 are filed under separate medwatch report number. The device will not be returned for evaluation; the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is being filed to report the leak and thrombus requiring intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. The clip delivery system (cds) was advanced to the mitral valve when thrombus was noted on the tip of the clip. The cds was removed without issue. Before insertion of the second cds, it was noted thrombus was on the tip of the steerable guide catheter (sgc) and in the inner lumen. Aspiration was performed without success and air was noted in the sgc hemostatic valve. The air was aspirated from the sgc and the handle was positioned below the level of the left atrium (la) to allow blood to fill the guide lumen. The sgc was then removed and replaced with a new one. The procedure was completed with two clips implanted, reducing mr to 1-2. There was no clinically significant delay in the procedure and no adverse patient sequela. 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 Key14553648
MDR Text Key293185844
Report Number2024168-2022-05820
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSGC0702
Device Lot Number11019R133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2021
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: 05/31/2022 Patient Sequence Number: 1
Treatment
STEERABLE GUIDE CATHETER
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