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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 Patient Involvement (2645)
Event Date 11/17/2020
Event Type  malfunction  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The additional mitraclip device referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report leak. It was reported that prior to the procedure, the steerable guide catheter (sgc), would not hold column during preparation. The sgc was tested three more times, but failed to hold saline. Additionally, during preparation of the clip delivery system (cds), the clip opened while locked when establishing the final arm angle/efaa. The clip was tested three additional times, but the clip would still open when locked. However, the patient experienced a pericardial effusion (pe) after the transseptal puncture was performed and the procedure was aborted. Therefore, replacement devices were not used. The sgc and cds was not used in the patient. 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 Key10961324
MDR Text Key220228514
Report Number2024168-2020-10229
Device Sequence Number1
Product Code DRA
UDI-Device Identifier08717648231025
UDI-Public08717648231025
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 03/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/04/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00928U956
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 Received02/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2020
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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