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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 SGC0701
Device Problem Leak/Splash (1354)
Patient Problems Air Embolism (1697); Stroke/CVA (1770)
Event Date 09/22/2021
Event Type  Injury  
Manufacturer Narrative
The device location was not provided, and it is unknown if the device is returning for analysis. A follow-up report will be submitted with all additional relevant information. The udi is unknown due to the part/lot number was not provided. The additional device referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report clip open, leak, air embolism and medical intervention. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with grade of 4+. The steerable guide catheter (sgc) was advanced to the mitral valve without issue. Then the first clip delivery system (cds) was advanced to the mitral valve, and the clip was deployed, reducing mr. However, the clip opened passed 60 degrees and mr increased. Although the clip is stable on both leaflets, a second clip was deployed to stabilize the opened clip a bit more. The physician stated that at some point during the procedure, one of the saline bags emptied and air bubbles entered the atrium resulting in a clinically significant delay. The saline bag was changed and aspirations were performed to remove the air. It was noted there was no reported issue connecting the sgc to the saline bag. The patient is stable. Two clips were implanted, reducing mr to 2-3. Then as of (b)(6) 2021, the patient is not doing so well. The physician stated it is uncertain if the air embolism is the reason for the patient's condition. 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 Key12642695
MDR Text Key276947312
Report Number2024168-2021-09277
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 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/10/2022
Device Catalogue NumberSGC0701
Device Lot Number10311U129
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2021
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: 10/15/2021 Patient Sequence Number: 1
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