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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 Positioning Failure (1158); Difficult to Remove (1528)
Patient Problem Pericardial Effusion (3271)
Event Date 06/14/2021
Event Type  Injury  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report a pericardial effusion. It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. It was noted the patient had a small left atrium (la) and visibility was poor. The steerable guide catheter (sgc) was inserted, but it was noted that due to a suboptimal transseptal puncture, the sgc was not able to turn in the posterior direction and became caught in tissue between the aorta and atrium, resulting in a pericardial effusion. Resulting in a clinically significant delay in the procedure. After several maneuvers were performed, the device was removed from the tissue, but continued to worsen the effusion. To treat the effusion, pericardiocentesis was performed. The physician then decided to undergo mitral valve replacement surgery. 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 Key12127726
MDR Text Key260238341
Report Number2024168-2021-05758
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/15/2022
Device Catalogue NumberSGC0702
Device Lot Number10212U201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2021
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: 07/07/2021 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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