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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 Failure to Advance (2524); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report a torn soft tip it was reported that on (b)(6) 2019, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4. An ntr clip was placed on the mitral valve, reducing mr to a grade of 1. On an unknown date, the patient returned to the hospital and echocardiography showed mr had increased to a grade of 4. The clip remained stable and the physician stated the recurrent mr was due to a progression of disease. On (b)(6) 2021, an additional mitraclip procedure was performed. The steerable guide catheter (sgc) was inserted, but was unable to pass through the septum. Therefore, the sgc was removed. Upon removal, it was observed the soft tip had become torn. A new sgc was inserted without issues and one clip was placed on the mitral valve, reducing mr to a grade of 1. There were no adverse patient effects and no clinically significant delay occurred. 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 Key12336828
MDR Text Key267089779
Report Number2024168-2021-07248
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 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/23/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10224U147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2021
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: 08/18/2021 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIP
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