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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 Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 07/22/2021
Event Type  Injury  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional device referenced are filed under separate medwatch report number.
 
Event Description
This is filed to report difficult to remove, delay, prolonged hospitalization, and surgical intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. A steerable guide catheter (sgc) was advanced to the mitral valve without issue. Then a clip delivery system (cds) was inserted in the sgc and advanced to the mitral valve. The clip grasped the leaflets fine; however, the clip would not completely close. It was noted that the arm positioner felt extremely tight and the clip would only close half way. Troubleshooting was performed and the clip appeared to be functioning properly. Therefore, the clip re-grasped the leaflets and the clip was locked sooner this time. However, the arm positioner felt tight again and the clip would not fully close. The clip was inverted and retracted back to the left atrium. The clip would still not fully close and so the clip was forced closed. The clip seemed closed, but when the clip was retracted back into the guide, the mandrel shaft separated and the clip became stuck at the tip of the guide. The soft tip of the sgc looked asymmetrical. Both the sgc and cds were being removed as a single unit, but the clip became stuck at the femoral groin causing a clinically significant delay. Tissue was observed in the clip. The physician stated that the tissue possibly came from the femoral vein. The patient remained hospitalized and a surgical cut-down was performed to remove the sgc and cds. The patient is stable and is pending another mitraclip procedure. No clips were implanted, and mr is 4. 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 Key12294215
MDR Text Key265764155
Report Number2024168-2021-06950
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 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/30/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10331R136
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2021
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: 08/09/2021 Patient Sequence Number: 1
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