• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE Back to Search Results
Model Number SGC0701
Device Problems Difficult to Flush (1251); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
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 filed to report the steerable guide catheter air leak. It was reported that this was a mitraclip procedure performed to treat grade 4+ mixed mitral regurgitation (mr). The patient has scoliosis and curves in the vena cava. The steerable guide catheter (sgc) was advanced into the left atrium. Air was observed in the sgc, the sgc could not be aspirated. The tip of the sgc was not up against the wall, nothing was blocking the sgc tip. The sgc was retracted to the inferior vena cava but again the sgc could not be aspirated. There was no damage observed and no thrombus. Air did not enter the patient. The sgc was removed and was replaced. One clip was implanted, reducing mr to 1-2. There were no adverse patient effects and no clinically significant delay in the procedure. The sgc was tested outside of the anatomy, the sgc was flushed without issue. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13457312
MDR Text Key288608934
Report Number2024168-2022-01196
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10915R560
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-