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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2022
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The additional mitraclip device is filed under separate medwatch report number.
 
Event Description
This is being filed to report the leak requiring aspiration. It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3. The steerable guide catheter (sgc) was inserted without issues. However, while inserting the clip delivery system (cds), a loss of fluid column occurred. Air entered the device and aspiration was performed. It was noted that no air entered the anatomy. The cds was removed and attempted to be reinserted; however, the same issues occurred. While removing the cds for a second time, it became caught on the clip introducer (ci). The physician was able to remove the clip from the ci and remove the cds from the sgc. The sgc was then removed and replaced. One clip was deployed on the mitral valve, reducing mr to a grade of <1. There was 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 Key14352824
MDR Text Key291354175
Report Number2024168-2022-05123
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number11130R150
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2021
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: 05/11/2022 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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