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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 Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report unintended movement. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4. It was noted dilated left atrium and a rotated heart that caused image difficulties. Both the steerable guide catheter (sgc) and the clip delivery system (cds) were advanced to the mitral valve; however, the sgc moved in an unintended direction. It was also difficult for the sgc to guide the cds properly due to image difficulty and the clip could not grasp both leaflets properly. Therefore, both the sgc and cds were removed from the patient and the procedure was aborted. No clips were implanted, and mr is 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 Key13399738
MDR Text Key288057172
Report Number2024168-2022-01014
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSP
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
Type of Report Initial,Followup
Report Date 02/23/2022
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 Catalogue NumberSGC0702
Device Lot Number10722R331
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2021
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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