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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Perforation (2001)
Event Date 03/09/2021
Event Type  Injury  
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. The mitraclip device referenced is filed under separate medwatch report number. Na.
 
Event Description
This is filed to report the perforation worsened during use of the steerable guide catheter. It was reported this was a mitraclip procedure performed to treat mixed mitral regurgitation (mr) grade 4. When gaining access, the needle that was used perforated the artery. When the steerable guide catheter (sgc) was advanced, the perforation in the artery worsened. The clip delivery system (cds) were advanced. Clip deployment was started; however, after retracting the lock line about 6-7mm, the lock line was stuck inside the handle. After pulling on the lock line several times, the lock line was able to be removed. The clip was implanted, reducing mr to 2-3. The cds was removed and examined. There were no knots or kinks on the line. Upon removal of the device from the groin; a hematoma was observed as a result from the perforation. The hematoma was treated surgically. Hospitalization was prolonged due to the surgical treatment of the artery. 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 Key11606491
MDR Text Key243583007
Report Number2024168-2021-02667
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 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/21/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number01222U158
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 Received05/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2020
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: 04/01/2021 Patient Sequence Number: 1
Treatment
STEERABLE GUIDE CATHETER
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