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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
Model Number SGC0701
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Atrial Perforation (2511)
Event Date 10/08/2020
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 will be filed to report the atrial septal defect. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with grade 4. The steerable guide catheter (sgc) was advanced and two clips were implanted, reducing mr to 1-2. During the procedure, a tear was noticed at the septum creating a 19 mm atrial septal defect (asd). At the end of the procedure, the decision was made to close the asd with a 22 mm amplatzer device. 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 Key10755302
MDR Text Key213663708
Report Number2024168-2020-09023
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeCA
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 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/18/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00318U110
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 Received11/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2020
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: 10/29/2020 Patient Sequence Number: 1
Treatment
2 IMPLANTED MITRACLIPS
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