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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE

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ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE Back to Search Results
Model Number SGC0701
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2020
Event Type  malfunction  
Manufacturer Narrative
All available information was investigated and the reported steerable guide catheter (sgc) leak was not confirmed during return device analysis as no issues were noted during testing. A review of the lot history record revealed no manufacturing nonconformities reported to this lot that would have resulted in this event. Additionally, a review of the complaint history identified no other complaints reported from this lot. All available information was investigated and a conclusive cause for the reported leak could not be determined in this complaint. There is no indication of a product issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report a leak. It was reported that during preparation of the steerable guide catheter (sgc), a loss of fluid column occurred. No aspiration was performed and the physician decided to not use the sgc; therefore, it was replaced. There was no clinically significant delay in the procedure. No additional information was provided.
 
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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 Key10900302
MDR Text Key219542629
Report Number2024168-2020-09900
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190167
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 11/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/26/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00827U121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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