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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 Problems Air Embolism (1697); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Event Date 02/03/2022
Event Type  Injury  
Event Description
This is filed to report leak, air embolism, delay and prolonged hospitalization, and medical intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4. A steerable guide catheter (sgc) was advanced to the mitral valve; however after the dilator was retracted from the sgc, air was observed in the guide. Additionally, the echocardiographer observed air in the apex of the heart causing a clinically significant delay in the procedure. The air was then immediately aspirated from the guide and a pigtail catheter was advanced to the heart to fully remove the air from the heart. Then the procedure continued and the clip delivery system (cds) was inserted into the sgc. However, prior to the clip reaching the heart, the patient's blood pressure quickly dropped and the patient was resuscitated. The cds was immediately removed with the clip attached and the sgc was retracted from the heart into the vena cava inferior. The procedure was paused to place an impella pump and perform cardial reanimation. When the impella was positioned and taking over the pumping, a decision was made to continue with the mitraclip procedure. A new sgc was being prepared for use due to the origin of the air seemed unclear. During preparation of the new sgc, the patient's blood pressure dropped again and the patient required cardial reanimation again. The initial sgc was removed from the patient and the mitraclip procedure was aborted. The echocardiographer assumed that some air went into the coronaries as the right heart did not have any ejection fraction (ef) anymore, an extracorporeal membrane oxygenation (ecmo) was installed to keep the patient stable. The patient is currently stable, but in critical condition in the intensive care unit and will remain hospitalized. No clips were implanted, and mr is 3-4. No additional information was provided.
 
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
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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 Key13569126
MDR Text Key288630976
Report Number2024168-2022-01756
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSGC0702
Device Lot Number10909R115
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2021
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: 02/21/2022 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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