• 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 STEERABLE GUIDE CATHETER VALVE REPAIR

  • 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 STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number SGC0301
Device Problems Break (1069); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2019
Event Type  Injury  
Manufacturer Narrative
The device was reportedly discarded and will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. (b)(4).
 
Event Description
This will be filed on steerable guide catheter for hemostasis valve break and air leak. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+ and a posterior leaflet flail. The steerable guide catheter (sgc) was advanced and while up against the lateral wall of the left atrium, as the dilator was being taken out and the wire out of the sgc, a vacuum was created and air was being pulled into the device. Aspiration was done. While attempting to remove the clip delivery system (cds) from the anatomy, there was difficulty getting the clip into the introducer while in the left atrium. Troubleshooting attempts were done successfully getting the clip into the introducer. As the introducer was retracted during aspiration, prior to coming out the hemostasis valve, it was noted that the hemostasis valve was over stretched and tore. The devices and undeployed clip were removed and replaced with a new device. No air entered the anatomy. Post procedure mr was reduced to 2+. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
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 Key9342974
MDR Text Key167126782
Report Number2024168-2019-13737
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2020
Device Catalogue NumberSGC0301
Device Lot Number90713U224
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 Received11/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2019
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: 11/19/2019 Patient Sequence Number: 1
-
-