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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)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2021
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 a cable break. It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3. The mean pressure gradient was 2mmhg and a there was a restricted posterior leaflet. The steerable guide catheter (sgc) was inserted without issues. However, while removing the dilator, minus knob was taken off, but it was observed the sgc did not curve. A cable break was suspected, but the physician decided to continue with the procedure. After the clip delivery system (cds) was inserted, an aorta hugger was observed. The physician attempted to implant the clip, but after the leaflets were grasping, the gradient increased to 35mmhg. Due to the increase in gradient, the physician decided to remove the devices and discontinue the procedure. The gradient returned to 2mmhg. Mr remained at a grade of 3. The physician stated the increase in gradient was due to angle of the clip and patient anatomy. 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 Key12600460
MDR Text Key277199368
Report Number2024168-2021-09026
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/07/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10407R353
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 Received10/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2021
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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