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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 08/26/2021
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 perforation. It was reported this was a procedure to treat functional mitral regurgitation (mr) with a grade of 3. It was noted the mean pressure gradient was 1mmhg. Two clips were successfully implanted, reducing mr to a grade of 1. The gradient increased to 4mmhg. A third clip was attempted to be implanted, but the gradient increased to 6mmhg; therefore, the clip was removed. However, after the steerable guide catheter was retracted into the right atrium (ra), it was observed the sgc had caused a perforation on the fossa ovalis. No treatment was performed. After the devices were removed, the gradient returned to 4mmhg. There was 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 Key12498881
MDR Text Key272256522
Report Number2024168-2021-08284
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 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/20/2022
Device Catalogue NumberSGC0702
Device Lot Number10421R244
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 Received09/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2021
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: 09/20/2021 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM; IMPLANTED MITRACLIP (X2)
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