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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 Break (1069); Leak/Splash (1354)
Patient Problem Air Embolism (1697)
Event Date 10/19/2021
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report the steerable guide catheter leak. It was reported the mitraclip procedure was performed to treat grade 3 degenerative mitral regurgitation (mr). When the steerable guide catheter (sgc) was inserted into the left atrium, air bubbles were observed in the aorta. The air bubbles were successfully aspirated. Shortly after air bubbles were also discovered in the left atrial appendage which were also aspirated. Again, shortly after, air bubbles appeared in the left atrium, requiring aspiration. The decision was made to remove and replace the sgc. An air leak and broken valve is suspected; however, no visible damage was observed. No more air entered the patient with the new sgc. The procedure was finished successfully. One clip was implanted, reducing mr to 1. 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 Key12756214
MDR Text Key283832936
Report Number2024168-2021-10009
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSGC0702
Device Lot Number10629R422
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2021
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: 11/07/2021 Patient Sequence Number: 1
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