• 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
Catalog Number SGC0702
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Low Blood Pressure/ Hypotension (1914); Thrombosis/Thrombus (4440)
Event Date 05/12/2021
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 filed to report that thrombus on the steerable guide catheter (sgc) tip was noted and after the procedure, pulmonary embolism occurred. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 3-4. The patient had history of osteomyelofibrosis with thrombocytosis, cirrhosis of the liver child-pugh-a, atrial fibrillation, renal failure stage iii, as a result, which greatly increased risk of thrombosis. A few minutes after transseptal puncture, injection of heparin was administered through anesthesia. The steerable guide catheter (sgc) was advanced up to the septum and thrombus was noted at the tip of sgc. The sgc was left on the right side of the septum and heparin was injected into the anesthesia again. A slight drop in blood pressure was noted and stabilized on its own with medication. Activating clotting time (act) was controlled after a few minutes with good results. The thrombosis was subsequently no longer visible. The procedure was continued without problems. One clip was implanted, reducing mr to <1. After the procedure the same date, a pulmonary embolism occurred medication was administered. Cardiac decompensation extended and prolonged hospitalization. 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 Key11983624
MDR Text Key255951135
Report Number2024168-2021-04920
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2021
Device Catalogue NumberSGC0702
Device Lot Number01201U133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2020
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: 06/11/2021 Patient Sequence Number: 1
-
-