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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 Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017)
Patient Problem Perforation (2001)
Event Date 05/06/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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.
 
Event Description
This is filed to report perforation, surgical intervention, hospitalization. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation with a grade of 3-4. After inserting the stiff guide wire into the pulmonary vein, the steerable guide catheter (sgc) was inserted over the stiff wire. There was resistance during advancement of the sgc into the leg and a little bit of force was used. During this maneuver, the stiff wire jumped from the left atrium into the right atrium. The sgc was removed and it was seen that the wire was in the abdomen. It was assumed that the vein was perforated when the sgc was inserted. The procedure was aborted and the patient was brought to surgery. It should be noted that the dilator was used in this procedure in the correct sequence per the instructions for use (ifu). 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 Key11878098
MDR Text Key252699538
Report Number2024168-2021-04380
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/09/2022
Device Catalogue NumberSGC0702
Device Lot Number10210U147
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 Received07/12/2021
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: 05/25/2021 Patient Sequence Number: 1
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