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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 Problems Leak/Splash (1354); Difficult to Advance (2920)
Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914)
Event Date 01/25/2022
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history did not indicate a lot-specific product issue. All information was investigated and a cause for the difficult advancement and steerable guide catheter (sgc) leak cannot be determined. The reported air embolism resulting in hypotension appears to be related to the procedural conditions associated with the sgc leak. Air embolism and hypotension are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures. The unexpected medical intervention was a result of case-specific circumstances. There is no indication of a product issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report a leak, air embolism, medical intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3+. It was noted a previous implanted pacemaker, calcium on posterior annulus, and a cleft. The clip delivery system (cds) was to be advanced into the steerable guide catheter (sgc); however, during alignment, resistance felt when the cds was advancing through the sgc valve. Force was applied and the cds was able to be advanced into the sgc. Later in the procedure, the clip briefly interacted with the chords. The clip was freed with standard troubleshooting and the procedure continued. But then during clip deployment, the right atrium (ra) and right ventricle (rv) began filling with fluid. The patient's blood pressure dropped. An epi drip was begun, and the patient recovered from a possible air bubble in the right coronary artery. The patient's blood pressure returned to normal and the ra/rv was free from fluid. The clip was deployed without issue. One clip was implanted, reducing mr to 1. There was reported 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 Key13552641
MDR Text Key285818794
Report Number2024168-2022-01671
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 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10915R517
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2021
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: 02/17/2022 Patient Sequence Number: 1
Treatment
STEERABLE GUIDE CATHETER
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