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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number SGC0301
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 10/21/2019
Event Type  malfunction  
Manufacturer Narrative
The customer reported the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Exemption number e2019001.
 
Event Description
This is being filed to report a leak. It was reported that during preparation of a steerable guide catheter (sgc), loss of fluid column was observed. The sgc was not used in the patient. The procedure was successfully completed with a new sgc. There were no patient involvement and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameSTEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
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 Key9291632
MDR Text Key176609814
Report Number2024168-2019-13323
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
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 12/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/12/2019
Device Catalogue NumberSGC0301
Device Lot Number81112U110
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 Received11/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2018
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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