• 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); Positioning Failure (1158); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 07/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was discarded and will not return for analysis. Investigation is not yet complete. A follow-up report will be submitted with all additional, relevant information.
 
Event Description
This report is filed due to a suspected steerable guide catheter cable break. It was reported that during steerable guide catheter (sgc) preparation, the +/- knob was tested without any unusual resistance noted, when a pop was heard and the catheter was no longer deflecting upon +/- application. A cable break was suspected. The device was discarded and there was no patient involvement. No additional information was provided regarding this device issue.
 
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 Key8880939
MDR Text Key153991795
Report Number2024168-2019-10723
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 09/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/16/2020
Device Catalogue NumberSGC0301
Device Lot Number90517U124
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 Received08/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-