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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 Problem Air Embolism (1697)
Event Date 04/15/2022
Event Type  Injury  
Event Description
This is being filed to report the leak resulting in air embolism requiring intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc) was advanced to the mitral valve without issue. The first clip delivery system (cds) was successfully inserted into the sgc, and the clip was deployed. The cds was removed fine. Then a second cds was advancing into the sgc; however loss of fluid column was observed. Aspirations were performed. The cds was removed and re-inserted, but half way through, loss of fluid column was observed again. The sgc was immediately dropped down below the patient's body; however air embolized to the left atrium (la). Aspirations were performed, and the guide was able to remove all the air/air embolism. The patient was stable and the procedure continued. The sgc was removed and a new sgc was advanced to complete the procedure. The same cds was re-inserted into the sgc without issue and the clip was deployed, reducing mr to 1. There was no clinically significant delay in the procedure and no patient sequela. No additional information was provided.
 
Manufacturer Narrative
The return device analysis did not confirm the reported leak. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, based on the similar complaint review, there is no indication of a lot-specific product quality issue. Based on available information and return device analysis, the cause of the reported leak could not be determined. Additionally, the reported air embolism is a cascading effect of the reported leak. The reported air embolism is listed in the instructions for use as a known possible complication 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.
 
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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 Key14310552
MDR Text Key290935282
Report Number2024168-2022-04927
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 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number11201R249
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2021
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: 05/06/2022 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
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