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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
Catalog Number SGC0702
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160)
Event Date 12/15/2021
Event Type  Injury  
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 being filed to report the dissection requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.One clip was implanted, reducing mr to 1+.Three days post procedure the patient experienced a continuous loss of blood from a dissection on the femoral vein.A covered stent was implanted to stop the bleeding and the patient is in stable condition.No additional information was provided.
 
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 being filed to report the dissection requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.One clip was implanted, reducing mr to 1+.Three days post procedure the patient experienced a continuous loss of blood from a dissection on the femoral vein.A covered stent was implanted to stop the bleeding and the patient is in stable condition.No additional information was provided.
 
Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, the reported patient effect of vascular dissection appears to be due to patient morphology/pathology.The hemorrhage was due to the vascular dissection.Vascular dissection and hemorrhage are listed in the mitraclip instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
 
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Brand Name
G4 STEERABLE GUIDING CATHETER
Type of Device
CATHETER, 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 Key13171053
MDR Text Key285497079
Report Number2024168-2022-00102
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/11/2022
Device Catalogue NumberSGC0702
Device Lot Number10412R154
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
1 IMPLANTED MITRACLIP
Patient Outcome(s) Hospitalization; Hospitalization; Required Intervention; Required Intervention;
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