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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 UNK SGC07
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoxia (1918); Perforation (2001)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: date estimated. The udi number is not known as the part and lot number were not provided. The device location was not provided as this was based on a literature review. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report hypoxia, perforation, and medical intervention. It was reported through a research article that this was a mitraclip procedure to treat mitral regurgitation (mr). The patient presented with decompensated heart failure, severe mitral regurgitation, and elevated right-sided pressures. A steerable guide catheter (sgc) was advanced to the mitral valve, and 3 clips were successfully deployed, reducing mr to 1-2+. The sgc was removed. However, the patient became hypoxic which did not improve with oxygen delivery. A left-to -right shunt was observed. The shunt was treated with a closure device. A 30-day follow-up revealed resolution of orthopnea and an improved functional status. Mr is less than 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 Key11708945
MDR Text Key250415132
Report Number2024168-2021-03421
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 literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK SGC07
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 Received05/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/22/2021 Patient Sequence Number: 1
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