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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
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 device referenced in is filed under a separate medwatch report number.
 
Event Description
This is filed to report a leak. It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. One clip was deployed on the mitral valve. A second clip delivery system (cds) was inserted into the steerable guide catheter (sgc). However, the sgc lost column. The cds was pulled back, then reinserted. However, the sgc lost column again. The physician decided to remove the sgc and replace it. A new sgc was inserted without issues. However, after the cds was inserted, the sgc lost column. The cds was then removed and it was observed the clip introducer had become broken. Once removed, the top portion of the clip introducer detached from rest of the device. Therefore, the cds was replaced. A new cds was inserted and the sgc successfully help column. The physician stated the sgc leaks were due to the broken clip introducer. The clip was deployed on the mitral valve, reducing mr to a grade of 2. There were no adverse patient effects and no clinically significant delay in the procedure.
 
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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 Key12639527
MDR Text Key276662969
Report Number2024168-2021-09253
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/10/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number01211U152
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2020
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: 10/15/2021 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
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