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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
Catalog Number SGC0702
Device Problem Difficult or Delayed Positioning (1157)
Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Event Date 06/25/2021
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 tissue damage, surgical intervention and prolonged hospitalization it was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. It was noted enlarged atrium. There was resistance with the anatomy when the steerable guide catheter (sgc) was inserted through the inguinal region. Therefore, the sgc was expanded with a 20fr dilator and the sgc was re-inserted. The sgc was able to be advanced to the mitral valve, and the clip was deployed. After the sgc was removed without issues, the blood pressure dropped. A pressor agent was administered to stabilize the blood pressure. The patient remained hospitalized. One clip was implanted, reducing mr to 2. The next day, it was discovered that the iliac vein was damaged; and therefore, the vein was surgically treated. The patient is stable. 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 Key12197128
MDR Text Key262469890
Report Number2024168-2021-06222
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/09/2022
Device Catalogue NumberSGC0702
Device Lot Number10210U122
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 Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2021
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: 07/20/2021 Patient Sequence Number: 1
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