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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); Failure to Advance (2524); Unintended Movement (3026)
Patient Problems Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Event Date 12/14/2021
Event Type  Death  
Manufacturer Narrative
The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report unintended movement of the steerable guide catheter (sgc), pericardial effusion, cardiac tamponade, atrial perforation requiring surgical intervention and death. It was reported that this was a mitraclip procedure performed (b)(6) 2021 to treat degenerative mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc) was advanced to the atrial septum and resistance was encountered while advancing the sgc across the septum. Tenting was noted but was felt to be normal. As the physician continued to push and advance the sgc, the sgc jumped impacting the lateral left atrial wall causing pericardial bleeding and cardiac tamponade. The mitraclip procedure was aborted with no insertion or implantation of mitraclips and no reduction in mr. The patient underwent surgical intervention for pericardiocentesis and repair of atrial perforation. Despite intervention, following surgery the patient died on (b)(6) 2021. In the physician¿s opinion, the jumping of the sgc and subsequent impact to the atrial wall contributed to the patient¿s death. A clinically significant delay was reported. 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 Key13122026
MDR Text Key283077392
Report Number2024168-2021-12290
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
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 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10816R121
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2021
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: 12/30/2021 Patient Sequence Number: 1
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