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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 Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)
Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Event Date 03/09/2022
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 vascular injury requiring intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4. Upon insertion of the steerable guide catheter (sgc), resistance was noted after passing the inguinal region. The dilator was pulled back into the sgc lumen by about 5 mm, and the sgc was inserted after the dilator was pushed in. Fluoroscopic images confirmed the bending and slight resistance of the sgc; minus knob was applied however the tip was difficult to straighten due to the bending of the tip due to the anatomy. The sgc was advanced and the tip reached the left atrium (la). One clip was implanted, reducing mr to 1. When pulling back on the sgc, a vascular injury was noted. When the sgc was completely removed, the patients blood pressure dropped from 110 to 40. Medication was administered and ballooning was performed to stop the bleeding. Contrast showed leakage of blood from the common iliac vein, therefore a stent was implanted as treatment. After placement of the stent, the contrast results confirmed that complete hemostasis had not been achieved; therefore an additional stent was placed. Per the physician, the vascular injury was due to the step between the soft tip and the dilator. 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 Key13929570
MDR Text Key288036820
Report Number2024168-2022-03216
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 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSGC0705
Device Lot Number10805R110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/05/2021
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: 03/28/2022 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP
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