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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 Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device is expected to be returned for investigation. 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 the steerable guide catheter leak. It was reported that during preparation of the steerable guide catheter (sgc), after introducing the dilator into the sgc, water column inside the sgc immediately fell every time the dilator was advanced through the hemostasis valve with air entering through the hemostasis valve. This occurred seven times. The operator was alone during device preparation; therefore, it was not possible for him to put his finger on the guide tip during introduction of the dilator into the sgc. Otherwise preparation was done as per instructions for use (ifu). The device was not used, there was no patient involvement. A new sgc was used to complete the procedure. There was no clinically significant delay to the intended 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 Key11773664
MDR Text Key264134693
Report Number2024168-2021-03788
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 07/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/17/2021
Device Catalogue NumberSGC0702
Device Lot Number01218U105
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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