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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); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914)
Event Date 01/19/2022
Event Type  Injury  
Event Description
This report is filed as the steerable guide catheter lost the fluid column during use and air was observed in the anatomy. It was reported that on (b)(6) 2022, the patient presented with functional mitral regurgitation (mr) grade 4. A steerable guide catheter (sgc) was advanced. Once in position, air bubbles were observed in the heart anatomy and the sgc lost fluid column. The sgc was removed from the stabilizer and re-positioned below the patient. Aspiration was performed and the same sgc was left in position. The mitraclip delivery system was prepared. During preparation and before patient use, the stopcock had unexpectedly separated from the device. The same stopcock was placed back on the device. The device was successfully re-flushed without further issues. The mitraclip was successfully implanted without any issue or malfunction, reducing the mr to grade 1. Following clip implantation, air was observed once again in the anatomy. The patient had become hypotensive (systolic blood pressure in the 50¿s), compressions were performed, and medications were provided. Reportedly, the compressions were performed due to the hypotension. There was no cardiac arrest or myocardial infarction noted. There was no leak, or device issue regarding the mitraclip device once in the anatomy. The mitraclip device had been successfully re-prepped before insertion into the anatomy. The air was thought to be residual from the steerable guide catheter, although this was unable to be confirmed. The patient stabilized and was sent to the intensive care unit for further monitoring. On (b)(6) 2022 a brain mri was performed. Small lacunar infarct involving the superior right cerebellar hemisphere was noted along with chronic microvascular ischemic white matter disease and chronic hypertensive encephalopathy. Reportedly, the patient is doing well. No additional information was provided regarding this issue.
 
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The mitraclip device is filed under a separate medwatch report number.
 
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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 Key13502224
MDR Text Key286563354
Report Number2024168-2022-01379
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 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10826R351
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2021
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: 02/09/2022 Patient Sequence Number: 1
Treatment
1 CLIP DELIVERY SYSTEM
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