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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 Unintended Movement (3026); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2021
Event Type  malfunction  
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. The additional device referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report unintended movement. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. On (b)(6) 2021, the steerable guide catheter (sgc) was advanced to the mitral valve; however, advancement was difficult due to the high tortuosity of the femoral vein and the sgc was advanced too much in the left atrium. After the sgc crossed the septum, the clip delivery system (cds) was advanced through the sgc, but then the sgc and clip moved unintentionally. Then the clip went through the left atrium wall and came outside the heart wall, causing a clinically significant delay in the procedure. The procedure was aborted and was converted to surgery which resulted in the patient to remain hospitalized longer. The clip was extracted prior to surgery. Then the hole of the left atrium wall was patched and a drainage was placed. The patient arterial blood pressure was very low and a long massage was required to recover the patient. No clips were implanted, and mr is 4. On (b)(6) 2021, the patient died due to decompensation of organs following the surgery performed. No other 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 Key12983802
MDR Text Key282116405
Report Number2024168-2021-11477
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSGC0702
Device Lot Number10712R353
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2021
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: 12/13/2021 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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