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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 Embolism (1829)
Event Date 08/19/2020
Event Type  Injury  
Manufacturer Narrative
It was reported that the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report embolism. It was reported that on (b)(6) 2017, a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 4. Two clips were successfully implanted, reducing mr to a grade of 1-2. Over two years later, the patient returned to the hospital and echocardiography showed that mr had increased to a grade of 4. The two implanted clips were noted to be stable on the leaflets and the physician stated that the recurrent mr is due to progression of disease. On (b)(6) 2020, a second mitraclip procedure was performed to treat mr with a grade of 4. The clip delivery system (cds) was inserted and advanced into the left atrium (la); however, at this time, the physician observed a flickering object around the tip of the steerable guide catheter (sgc). The physician stated that it did not observe to be thrombus. Also, during the procedure, the patient was fully heparinized and the activated clotting time (act) remained well about 250. Roughly one minute after the foreign object was noticed, it was no longer visible. It was noted that it likely dislodged and migrated to an unknown location. The procedure was continued, and the clip was successfully implanted, reducing mr to a grade of 3. It was noted that after the procedure, the patient was stable and cleared of any neurological complications. 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 Key10515073
MDR Text Key206342023
Report Number2024168-2020-07539
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/17/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00317U323
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2020
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: 09/10/2020 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM; IMPLANTED MITRACLIP (X2)
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