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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 Crack (1135); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2022
Event Type  malfunction  
Event Description
This is filed to report the leak in the hemostasis valve. It was reported that, during preparation of the steerable guide catheter (sgc), fluid leaked from the hemostasis valve. The stopcock was replaced but the hemostasis valve still leaked. A crack was noted in the valve; therefore, it was replaced with another sgc. There was no patient involvement. There was no clinically significant delay. No additional information has been provided.
 
Manufacturer Narrative
The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
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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 Key14478873
MDR Text Key292492450
Report Number2024168-2022-05529
Device Sequence Number1
Product Code DRA
UDI-Device Identifier08717648231025
UDI-Public08717648231025
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/16/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10915R402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2021
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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