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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 Perforation (2001)
Event Date 05/27/2021
Event Type  Injury  
Manufacturer Narrative
The customer reported the device is not returning. 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 perforation, unable to straighten the device and a cable break. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+. The steerable guide catheter was inserted, but it was observed that when applying minus knob, the guide was unable to straighten. The physician suspected a cable break occurred; therefore, the clip was removed and replaced. It was noted that after the sgc was removed an atrial septal defect was observed. The physician decided no treatment was needed; therefore, a new sgc was inserted and one clip was successfully implanted, reducing mr to a grade of <1. 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 Key12009407
MDR Text Key256504338
Report Number2024168-2021-05037
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 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10129U126
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 Received06/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2021
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: 06/16/2021 Patient Sequence Number: 1
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