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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 Leak/Splash (1354); Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/28/2020
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.
 
Event Description
This is filed to report the steerable guide catheter (sgc) leak. It was reported that this was a mitraclip procedure to treat a degenerative mitral regurgitation (mr) with grade 4. The clip delivery system (cds) was advanced to the mitral valve and the clip was implanted successfully. The steerable guide catheter (sgc) was noted to have a leak as when aspiration was performed air was noted in the valve. There was no air introduced into the patient and there was no further aspiration required. The physician commented that during removal of the cds, the atraumatic tip was not fully inside the clip introducer and this could have damaged hemostatic valve of the steerable guide catheter (sgc). A new sgc had to be used to continue with the procedure. A second cds was advanced and the clip was deployed without issue. Two clips implanted, reducing mr to <1. There was no adverse patient effect and not 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 Key10174454
MDR Text Key195899111
Report Number2024168-2020-05178
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 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/03/2020
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00204U118
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 Received07/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/19/2020 Patient Sequence Number: 1
Treatment
1 IMPLANTED CLIP; CLIP DELIVERY SYSTEM
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