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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 Crack (1135); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2021
Event Type  Injury  
Event Description
This is filed for loss of fluid column, requiring intervention. 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 prepared for use and no issues were noted. The sgc was advanced into the groin and to the left atrium. The dilator and guide wire were removed and a loss of fluid column was noted. The sgc was removed from the stabilizer and the device was lowered below the patient's heart, in an attempt to pull back blood (aspirate). Blood could not be pulled and the dilator was re-inserted. Blood was able to be pulled back and no air was noted in the patient anatomy. The loss of fluid column remained and it was thought that perhaps there was a crack in the device near the hemostatic valve. All connections were noted to be tight. A second sgc was then prepared and used. One clip was implanted, reducing the dmr from grade 4+ to trace. There were no adverse patient effects or clinically significant delay. No additional information was provided.
 
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
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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 Key13048442
MDR Text Key285426131
Report Number2024168-2021-11930
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 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10812R150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2021
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: 12/20/2021 Patient Sequence Number: 1
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