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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2021
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no similar complaints reported from this lot. It should be noted that the mitraclip system instructions for use warns: ¿do not use the mitraclip system after the ¿use by¿ date stated on the package label. The investigation determined the reported improper or incorrect procedure or method (use after expiration) was due to the user error of using the device despite knowing the steerable guide catheter was expired. There is no indication of a product issue with respect to manufacture, design or labeling. (b)(4).
 
Event Description
This is filed to report the use of an expired device. It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. Prior to use, it was observed the steerable guide catheter (sgc) was expired. Although this was observed, the physician continued with the procedure. An ntw clip was inserted and grasping was performed. However, mr was unable to reduced; therefore, the clip was removed, and the procedure was discontinued. There were no adverse patient effects and 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 Key12599402
MDR Text Key275454907
Report Number2024168-2021-09015
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
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00730U336
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 Received09/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2020
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: 10/08/2021 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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