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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number SGC0302
Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Patient Problem No Patient Involvement (2645)
Event Date 10/05/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received. The investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report difficult removal of the dilator from the steerable guide catheter (sgc). It was reported that during preparation, the hemostatic valve on the steerable guide catheter (sgc) was very rigid. Resistance was felt when advancing the dilator into the sgc. The dilator could only be advanced and removed with force. The device was not used in the anatomy. There was no visible damage to the sgc hemostatic valve. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE 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 Key10744523
MDR Text Key213691942
Report Number2024168-2020-08956
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 12/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/24/2021
Device Catalogue NumberSGC0302
Device Lot Number00723U332
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2020
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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