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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 Difficult or Delayed Positioning (1157)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)
Event Date 10/21/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents reported from this lot. Based on available information, a cause of the reported difficult positioning and air embolism were due to procedural conditions. A cause of the reported ecg changes and hypotension could not be determined. The reported patient effects of hypotension, ekg/ecg changes (cardiac arrhythmias) and air embolism are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures. The reported unexpected medical intervention was a result of case-specific circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report air embolism, medical intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. The steerable guide catheter (sgc) was inserted into the patient when the st changed and the blood pressure decreased. Air was observed in the apex of the left ventricle. It was noted that there was some resistance when the sgc crossed the septum and while the sgc was at the septum, it is possible that traction on tissue caused suction and some air to form. The patient was placed in the trendelenburg position to remove the air and the patient's condition slowly improved. Therefore, the procedure continued and the sgc was advanced to the mitral valve. Then the clip delivery system (cds) was advanced to the mitral valve, and the clip was deployed. However the final mean pressure gradient was 8mmhg. Despite the increase in gradient, the physician was satisfied with the outcome. The patient was discharged. One clip was deployed, reducing mr to 1-2. There were no adverse patient effects and no 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 Key12787188
MDR Text Key280584410
Report Number2024168-2021-10198
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
Report Date 11/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/21/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10322R325
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2021
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: 11/10/2021 Patient Sequence Number: 1
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