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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 Break (1069); Positioning Failure (1158); Noise, Audible (3273); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2022
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.
 
Event Description
This is filed to report cable break it was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc) was advanced to the mitral valve. Then after a clip delivery system (cds) was advanced to the mitral valve without issue, resistance was felt when the + knob of the sgc was rotated approximately 1/2 a turn clockwise and the sgc tip would not curve. Reportedly, a pop sound was heard upon rotating the sgc knob and a cable break was suspected. The + knob was rotated counter clockwise back to neutral and then rotated 1/2 turn, but the sgc tip would still not curve. It was noted that although the cds performed as intended, a decision was made to remove the cds from the sgc and complete the procedure with a new cds. Additionally, the sgc was removed and the procedure continued with a new sgc. One clip was implanted, reducing mr to 3-4. There were no adverse patient effects and 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 Key13399982
MDR Text Key289102246
Report Number2024168-2022-01016
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 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/06/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10407R143
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2021
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: 01/31/2022 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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