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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 Problems Break (1069); Positioning Failure (1158); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2021
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 the possible steerable guide catheter cable break. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with an mr grade of 3. When inserting the steerable guiding catheter (sgc) (10115u112), into the pelvis through the femoral vein, the sgc did not advance due to a narrow point in the pelvis. The sgc was removed without issue. Once outside of the anatomy, the sgc was rinsed and the +/- knob was tested. It was observed that the sgc no longer curved with the +/- knob, possibly a cable break. A new sgc was prepped and was inserted. The sgc did not advance in the pelvis towards the septum. The sgc was removed and the procedure was aborted. No clips were implanted, mr remains at 3. There were no adverse patient effects and no clinically significant delay during 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 Key12294748
MDR Text Key265614088
Report Number2024168-2021-06969
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2022
Device Catalogue NumberSGC0702
Device Lot Number10115U112
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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