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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 N/A
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2022
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The two clip delivery system (cds) referenced are filed under separate medwatch report numbers.
 
Event Description
This is filed to report the loss of fluid column during device preparation. It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4+. During device preparation of the steerable guide catheter (sgc), there was loss of fluid column as soon as the dilator was inserted into the sgc. There was no patient involvement, and it was exchanged for a new sgc. The procedure began and one clip delivery system (cds 10816r117) was advanced and placed medially on the mitral valve. During deployment, after the clip was released from the cds, it opened to 25 degrees. However, the clip remained stable on the leaflets and the mr was reduced to a grade of 2+. A second cds (11014r259) was advanced to the mitral valve, and it was noted that there was shadowing due to the cds. While in the ventricle, the clip got caught in the chords because there was not enough height in the left atrium which made it hard to navigate. Standard troubleshooting was performed to maneuver the device back into the left atrium. However, it is believed to have caused a leaflet perforation. The physician proceeded with implanting the clip and it was deployed medially on a2/p2. After the clip detached from the cds it was noted to have opened to 20 degrees, but the clip remained stable on both leaflets and the procedure was complete. There was no clinically significant delay in the procedure and no adverse patient sequelae. 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 Key14496459
MDR Text Key292608751
Report Number2024168-2022-05599
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberSGC0701
Device Lot Number11109R328
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2021
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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