• 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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoxia (1918); Perforation (2001)
Event Date 03/16/2022
Event Type  Injury  
Event Description
This is being filed to report an atrial percutaneous intervention and a drop in oxygen saturation. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3+. Imaging was noted to be difficult due to shadowing. The clip delivery system (cds) was advanced and grasping was difficult due to patient anatomy, as there was a large coaptation gap. The clip was able to be implanted; however, after deployment, the clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda). An additional clip was implanted to stabilize the sdla clip. The mr was reduced to 2+. After the steerable guide catheter (sgc) was removed, an atrial septal defect (asd) was noted. An asd closure device was used for treatment; however, the patient was difficult to stabilize and the oxygen had dropped. The patient continued to be monitored and was extubated later. No additional information was provided.
 
Manufacturer Narrative
It is unknown if the device is returning for analysis. A follow-up report will be submitted with all additional relevant information. The cds referenced is filed under separate medwatch report number.
 
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 Key14053970
MDR Text Key288883327
Report Number2024168-2022-03763
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 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number11020R225
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2021
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: 04/08/2022 Patient Sequence Number: 1
Treatment
STEERABLE GUIDE CATHETER
-
-