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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 SGC0302
Device Problems Break (1069); Positioning Failure (1158); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 11/12/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. 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. Patient birth year: (b)(6).
 
Event Description
This is filed to report the cable break. It was reported that during preparation of the steerable guide catheter (sgc), when turning the +/- knob over 180 degrees in the minus direction a loud noise was heard. The sgc tip was no longer deflecting, unable to straighten. A cable break was suspected. The sgc was not used and was replaced. There was 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 Key9410561
MDR Text Key177766520
Report Number2024168-2019-14100
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161985
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 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/03/2020
Device Catalogue NumberSGC0302
Device Lot Number90502U107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2019
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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