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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 Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. Additionally, a review of the complaint identified no other complaint reported from this lot. Based on available information, a cause for the reported difficult to remove could not be determined. It was reported that the procedure was used to treat tricuspid regurgitation. It should be noted that the intended use section of the mitraclip g4 system, instruction for use states: ¿the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation¿ since, the device was used for a tricuspid valve procedure, this is considered as an off-label use of the device; however, it could not be determined if using the mitraclip on the tricuspid valve caused or contributed to the reported difficulties. There is no indication of product issue with respect to manufacture, design or labeling. The clip delivery system referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to captured difficult removal. It was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 4. It was noted the patient had slightly rotated heart. An xtw was inserted but was unable to be deployed due to difficult patient anatomy. When pulling the clip into the steerable guide catheter (sgc), resistance was felt. Therefore, the physician made the decision to remove both the sgc and clip delivery system (cds) at one time. Once outside the anatomy, it was observed that the braided sutures on one of the clip arms was no longer covering the clip. The procedure was discontinued and tr remained at a grade of 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 Key12860586
MDR Text Key281140882
Report Number2024168-2021-10728
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 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/09/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10610R131
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2021
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: 11/23/2021 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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