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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 Problems Air Embolism (1697); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Event Date 02/24/2022
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 mitraclip devices are filed under separate medwatch report numbers.
 
Event Description
This is being filed to report during the procedure, cardiac arrest occurred possibly due to air embolism from possibly the steerable guide catheter. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4. During preparation, the clip delivery system (cds) (cds0701-xtw, 10910r428) had bubbles in the delivery catheter handle. Attempts to eliminate the air bubbles let to more bubbles. Therefore, the cds was not used. A second cds (cds0701-xtw, 10910r426) was prepped successfully and advanced to the mitral valve. When positioning the clip, the patient blood pressure dropped, and went into cardiac arrest. Cardiopulmonary resuscitation (cpr) was performed. The patient was checked for a pericardial effusion, but there was none seen. The sgc and cds were flushed, and all valves were cleared. There were no issues noted with the devices. Medication and extra oxygen were given to the patient. The patient was stabilized, and the procedure continued. The patient¿s blood pressure dropped again and heart rate. The patient was stabilized again, but it was decided to end the procedure as it was suspected the patient had an air embolism but was not confirmed. Outside the patient anatomy, the cds was inspected and there appeared to be air bubbles in the cds shaft. It was then thought that the steerable guide catheter (sgc0701, 10915r207) might have had a leak and not noted. The patient was stable after 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 Key13832229
MDR Text Key287800906
Report Number2024168-2022-02900
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10915R207
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2021
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: 03/20/2022 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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