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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 Leak/Splash (1354)
Patient Problem Bradycardia (1751)
Event Date 02/10/2021
Event Type  malfunction  
Manufacturer Narrative
The device was not returned. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no other incidents reported from this lot. All available information was investigated and a cause for the reported leak could not be determined. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report leak. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (dmr) with a grade of 4. Prior to the procedure and during prep of the steerable guide catheter (sgc) the sgc failed prep as it could not hold the fluid column. It was attempted twice but still failed so a new sgc was prepped and was able to be used. The clip delivery system (cds) was then advanced to the mitral valve and when it was placed, the mean pressure gradient increased to 7 mmhg and heart rate was 60. The clip was moved and placed again, and again the mean pressure gradient went to 7 mmhg, heart rate 60. Finally it was decided to invert the clip and remove it from the anatomy. No treatment was performed for the bradycardia. A new nt cds was advanced and implanted and the mean pressure gradient was 5 mmhg and mr was reduced to 2. There was 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 Key11387890
MDR Text Key240316089
Report Number2024168-2021-01514
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
Report Date 02/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00928U223
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 Received02/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2020
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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