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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 SGC0702
Device Problem Difficult or Delayed Positioning (1157)
Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Shock (2072); Tachycardia (2095); Perforation of Vessels (2135)
Event Date 02/24/2022
Event Type  Death  
Event Description
This is filed to report the patient death. It was reported that a mitraclip procedure was performed to treat functional grade 3+ mitral regurgitation (mr). The steerable guide catheter (sgc) was inserted in right femoral vein over the guidewire. Resistance was felt with the femoral vein, the sgc was removed, and the femoral vein was predilated once again followed by sgc insertion under fluoroscopic guidance. When the tip of sgc was placed into left atrium, the patients¿ blood pressure lowered to systolic 65mmhg. No injury was observed. The procedure was continued, one clip was implanted, reducing mr to <1. Blood pressure was stable throughout the rest of procedure around 90-110mmhg with normal heart rhythm. Volume contrast imaging (vci) was injected through the sgc flush port while retracting sgc into femoral vein. Extravasation was noted at the femoral vein/ iliac vein. A 22mmx112mm stent graft was placed and surgical intervention were attempted to treat the vein injury; however, extravasation did not stop. Blood pressure dropped, the heart rhythm increased, massive bleeding was noted which at the end could not be stopped or repaired despite all efforts. The patient went into shock, no treatment was possible resulting in death. Per the physician, it cannot be determined which device caused the injury and patient death, it could be related to a combination of catheter(s)/ wire manipulation(s), sgc insertion, and or pre-existing anatomy. No additional information was provided.
 
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.
 
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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 Key13773007
MDR Text Key287240711
Report Number2024168-2022-02670
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeNL
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 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSGC0702
Device Lot Number10914R144
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2021
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: 03/15/2022 Patient Sequence Number: 1
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