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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 No Patient Involvement (2645)
Event Date 12/10/2020
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 that would have contributed to the reported issue. Additionally, a review of the complaint history identified no similar incidents reported from this lot. All available information was investigated and without a device to analyze a cause for the reported leak could not be determined. There is no indication of a product issue with respect to manufacture, design or labeling. Na.
 
Event Description
This is filed to report the device leak. It was reported that this was an off label mitraclip procedure to treat grade 5 tricuspid regurgitation (tr). During preparation of the steerable guide catheter (sgc), it was noted that the fluid column was not holding column. This was attempted three times, but it would not hold column; therefore, the device was not used in the patient. Another sgc was used to complete the procedure. There was no additional information 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 Key11077327
MDR Text Key223795050
Report Number2024168-2020-10952
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 12/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00928U453
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 Received12/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2020
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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