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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 Difficult or Delayed Positioning (1157)
Patient Problem Thrombosis (2100)
Event Date 11/16/2020
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 is being filed to report the blood clot requiring aspiration. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc) was advanced with resistance noted when passing through the septum. After removing the dilator and guide wire, a bright object thought to be a blood clot was noted on echo on the tip of the sgc. Aspiration was performed however the blood clot could not be removed. The decision was made to continue the procedure. The clip delivery system (cds) advanced to the left atrium (la) and the grippers tested. The gripper on the anterior side lowered without issue however the gripper on the posterior side would not lower. The lock lever was changed to the locked position and both grippers were able to lower; however the gripper lever latch came off. The physician continued with use of the device and the clip implanted without further issues. After removal of the cds, the sgc tip was confirmed on echo and the blood clot was gone. The sgc was removed and the procedure completed with the mr reduced to 1. There was no clinically significant delay in the procedure and no adverse patient effects. 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 Key10986748
MDR Text Key220909520
Report Number2024168-2020-10388
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/21/2021
Device Catalogue NumberSGC0705
Device Lot Number00821U340
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 Received01/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2020
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: 12/10/2020 Patient Sequence Number: 1
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