• 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 Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 10/17/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. Product performance engineering reviewed the incident information provided to abbott vascular, manufacturing records, complaint history for the reported lot and performed analysis of the returned device. Based on the returned device analysis the reported leak could not be confirmed. The discrepancy between what was reported (inability to de-air) and what was observed (successful de-airing with no leakage) may have been due to the user technique while de-airing/aspiration of the sgc during preparation versus the returned product analysis. In conclusion a definitive cause for the reported leak could not be determined in this incident. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no similar incidents reported from this lot. There is no indication of a product issue with respect to manufacture, design or labeling.
 
Event Description
This is being filed to report a leak. It was reported that during preparation of a steerable guide catheter (sgc), it was not possible to de-air the sgc indicating a possible leak. The procedure was successfully completed with a new sgc. There was no patient involvement and no clinically significant delay in the procedure. 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 Key9280527
MDR Text Key175226971
Report Number2024168-2019-13223
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
Report Date 11/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2019
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/21/2020
Device Catalogue NumberSGC0301
Device Lot Number90722U157
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-