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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 Problems Crack (1135); Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 12/16/2020
Event Type  malfunction  
Manufacturer Narrative
The device was discarded. Investigation has not yet been completed. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This will be filed to report the touhy of the steerable guide catheter was leak. It was reported that during preparation of the steerable guide catheter (sgc), it was observed that the touhy had a crack and was leaking. A new sgc was used in the procedure. There was no patient involvement and 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 Key11125339
MDR Text Key225781105
Report Number2024168-2021-00145
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,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/23/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00824U110
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 Received01/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2020
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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