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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative
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 filed to report perforation, intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (fmr) with a grade of 4. A guide wire was advanced with difficulty due to the anatomy and became kinked. The steerable guide catheter (sgc) was advanced in a very tortuous vein to the right atrium and before being inserted into the left atrium, the patient experienced a drop in blood pressure and rhythm changes. Medication was given for the blood pressure and no treatment was performed for the rhythm changes. The sgc then went transseptal and the hemodynamics stabilized. Next, the clip delivery system (cds) was prepped and then advanced to the mitral valve. Again, the patient's blood pressure dropped and there were rhythm changes. There was a perforation noted to the femoral vein and it may have been caused by the kink in the wire; otherwise the cause is unknown. The sgc was removed and an unspecified covered stent was used to seal the perforation. The cds was then removed with the clip still attached and the patient stabilized. Mr remains the same as no clips were implanted. The patient required 3 units of blood. Final patient outcome is good. 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 Key11530945
MDR Text Key241564433
Report Number2024168-2021-02194
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 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/17/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number01217U114
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 Received03/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2020
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: 03/19/2021 Patient Sequence Number: 1
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