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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
Catalog Number SGC0702
Device Problems Break (1069); Positioning Failure (1158); Noise, Audible (3273); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 02/25/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report cable break. It was reported that during preparation, the steerable guide catheter (sgc) was prepared per the instructions for use. While preparing the guide for insertion, minus was applied to straighten the guide. However, after turning the knob in the minus direction, resistance was noted. The knob was turned back to neutral, then minus was again applied. Resistance was again felt, but this time, a rupture sounds was heard and is was suspected that a cable break occurred. The sgc was then unable to straighten; therefore, the device was not used and 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 Key11542837
MDR Text Key243195271
Report Number2024168-2021-02210
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/15/2021
Device Catalogue NumberSGC0702
Device Lot Number01016U140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2020
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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