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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 Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 07/28/2021
Event Type  Injury  
Manufacturer Narrative
The device will not be returned for evaluation; the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is being filed to report the thrombus requiring medical intervention. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+. During transseptal puncture, heparin was given but it was noted that the heparin was administered through a line that was not in the patient anatomy. The heparin line was connected properly, and the procedure continued. The steerable guide catheter (sgc) was advanced to the right atrium, and thrombus was noticed on the guide wire in the right atrium about the size of a nickel. The sgc was removed and a 6fr guiding catheter was advanced in an attempt to remove the thrombus. The guide wire was removed and the physician thought the clot had dislodged and re-crossed the guide wire to the septum through the same access site, all looked good. However, when the sgc was re-inserted, a larger thrombus was noted attached to the guide wire. Therefore, the physician decided to abort the procedure due to the patient coagulation issue. There were no clips implanted, mr remained at 4+. 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 Key12320945
MDR Text Key266623597
Report Number2024168-2021-07153
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 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/23/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number01024U202
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 Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2020
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: 08/13/2021 Patient Sequence Number: 1
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