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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 Problems Difficult to Insert (1316); Leak/Splash (1354)
Patient Problems Air Embolism (1697); Bradycardia (1751); Non specific EKG/ECG Changes (1817)
Event Date 11/16/2021
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 leak, air embolism, bradycardia, and medical intervention. It was reported that this was mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. It was noted that the dilator was inserted with difficulty during preparation. The steerable guide catheter (sgc) was advanced to the mitral valve; however, after removal of the dilator from the sgc, an air embolism was suspected. The st-elevation reduced contractility and reduced heart rate. Chest compression were performed. Additionally, inotropic agents and temporary pacing were applied. After 2-3 minutes, the patient recovered and the procedure continued without issues. Two clips were implanted, reducing mr to 2. The next day, the patient was still stable. There was no reported 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 Key12934759
MDR Text Key281753402
Report Number2024168-2021-11096
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeDA
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 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/15/2022
Device Catalogue NumberSGC0702
Device Lot Number10212U332
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2021
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: 12/06/2021 Patient Sequence Number: 1
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