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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 Product Quality Problem (1506); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2020
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 mitraclip system and implanted clip referenced are filed under a separate medwatch report numbers.
 
Event Description
This is filed to report damaged steerable guide catheter hemostasis valve (00225u828). It was reported this was a mitraclip procedure performed to treat grade 4 mixed mitral regurgitation (mr). The steerable guide catheter (00225u828) was inserted and the mitraclip delivery system (cds) (00310u167) was advanced to the mitral valve. The leaflets were grasped without issue; however, the clip repeatedly failed to establish final arm angle (efaa), and troubleshooting was unsuccessful. The clip was not implanted. When removing the cds, the fully closed clip got caught on the clip introducer and the tip of the clip introducer became mangled, causing damage to the sgc hemostasis valve. The clip was fully closed but could not be removed from the sgc hemostasis valve. The devices were removed together. A new sgc and cds (00310u166) were advanced. Grasping was successful and the clip was implanted without issues, reducing mr to 2. It is suspected the implanted clip (00310u166) caused an anterior leaflet tear. In an attempt to further reduce mr, another clip was advanced and grasping was successful. However, mr would not reduce any further; therefore, the clip was not implanted and was removed. No attempt was made to treat the anterior leaflet tear. A total of one clip was implanted, mr was reduced to 2. 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 Key10434320
MDR Text Key204049296
Report Number2024168-2020-06974
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 10/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/23/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00225UA28
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 Received09/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2020
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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