• 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 SGC0705
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Heart Failure/Congestive Heart Failure (4446)
Event Date 01/31/2022
Event Type  Injury  
Event Description
This is being filed to report perforation requiring intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. One mitraclip was successfully implanted reducing the mr to a grade of 1. Following the procedure, the patient experienced right heart failure and intervention was performed to close the atrial septal defect (asd). There was no clinically significant delay in the procedure and no adverse patient effects. 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.
 
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 Key13571062
MDR Text Key287526057
Report Number2024168-2022-01792
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
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 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/21/2022
Device Catalogue NumberSGC0705
Device Lot Number10622R101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2021
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: 02/21/2022 Patient Sequence Number: 1
-
-