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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 02/09/2021
Event Type  Injury  
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 device referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report tissue damage. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc) was prepped per the instructions for use and was inserted without issues. However, when the sgc crossed the septum, an object was noticed on the tip of the sgc; therefore, aspiration was performed. The object was unable to be removed, so the physician decided to remove the entire device. Once outside the anatomy, it was noticed that 1-2cm of tissue was stuck to the tip of the sgc. The physician felt as though the tissue damage was caused during advancement of the sgc. Once the tissue was removed, the sgc was reinserted. An ntw clip was then implanted without issues. To further reduce mr, a second clip was inserted and deployed laterally of the ntw clip. However, after the clip was deployed, the ntw clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda). The clip was stable on the posterior leaflet and mr was reduced to a grade of 2, so the physician decided to not implant an additional clip and discontinue the procedure. 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 Key11405602
MDR Text Key234483982
Report Number2024168-2021-01679
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 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/19/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number01120U311
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 Received03/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2020
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: 03/03/2021 Patient Sequence Number: 1
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