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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 SGC0705
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 12/14/2021
Event Type  Injury  
Event Description
This is filed to report the atrial septal defect (asd) requiring intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3. The clip delivery system (cds) was advanced to a2p2 and placed. Establishing final arm angle (efaa) was performed with no issue, but when removing the lock line, the clip jumped opened to 60 degrees. Efaa was performed again with no problem, however the decision was to remove the cds. A new cds was advanced in the patient and implanted, reducing final mr to a grade of <1. As the steerable guide catheter (sgc) was being removed, a large defect was found in the atrial septum. The defect was closed using an amplatzer septal occluder. There was no clinically significant delay in the procedure and no adverse patient sequela. No additional information was provided.
 
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. The additional mitraclip device is filed under a separate medwatch report number.
 
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. The additional mitraclip device is filed under a separate medwatch report number.
 
Event Description
This is filed to report the atrial septal defect (asd) requiring intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3. The clip delivery system (cds) was advanced to a2p2 and placed. Establishing final arm angle (efaa) was performed with no issue, but when removing the lock line, the clip jumped opened to 60 degrees. Efaa was performed again with no problem, however the decision was to remove the cds. A new cds was advanced in the patient and implanted, reducing final mr to a grade of <1. As the steerable guide catheter (sgc) was being removed, a large defect was found in the atrial septum. The defect was closed using an amplatzer septal occluder. There was no clinically significant delay in the procedure and no adverse patient sequela. 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 Key13119437
MDR Text Key285404046
Report Number2024168-2021-12277
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
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 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSGC0705
Device Lot Number10618R228
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2021
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: 12/30/2021 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
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