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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 Difficult or Delayed Positioning (1157); Positioning Failure (1158); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report that the inability to straighten the steerable guide catheter tip. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4. The patient from this procedure had heavy tortuosity in their femoral vein. There was difficulty in advancing the dilator and guide up through the vasculature and into the right atrium. The steerable guide catheter (sgc) and the dilator were advanced normally over the guide wire without success. The sgc was unable to navigate the bend. Contrast was applied into the formal vein to visualize any blockages and there were none. The guide wire was changed to a different guide wire. A buddy guide wire was used in the femoral vein to try and help straighten the vasculature in addition to the new guide wire. In doing this, the dilator was advanced out further and it allowed the sgc to advance through the vasculature and into the right atrium. The sgc was then advanced across the septum and into the left atrium (3 cm). The sgc was facing directly towards the pulmonary artery. When the physician tried to apply posterior and anterior guide torque to rotate the tip of the guide to a safer position the guide handle would rotate but the guide tip would not rotate. The guide handle was properly secured but the handle had resistance when trying to apply guide torque and when it was let go it settled back to neutral position slowly. Due to safety concerns around non-reliable steering, the sgc was removed. After the procedure, the sgc was noted to have significant set bends in the shaft from the vasculature which the physician attributed to causing the lack of rotation ability for the guide tip. There were no clips implanted as a clip could not be safely inserted in the left atrium as the guide was pointing towards the hear and would not respond to steering. The mr remained at 4. There was no adverse patient effect and 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 Key11378507
MDR Text Key234987145
Report Number2024168-2021-01460
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 04/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/19/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number01120U143
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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