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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
Model Number UNK SGC03
Device Problem Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2014
Event Type  malfunction  
Manufacturer Narrative
Attachment article, titled: "cerebral protection during mitraclip implantation. ¿ exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period. The device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The clip delivery system (cds) mentioned in the article is filed under a separate medwatch report number. Na.
 
Event Description
This is being filed to report peeling. It was reported through a research article identifying mitraclip and that may be related to the following:mitral stenosis, tissue damage, thrombosis, foreign material, embolism and prolonged hospitalization. The article also identified steerable guide catheters that may be related to the following: thrombosis, tissue damage, foreign material, prolonged hospitalization and peeling. Specific patient information is documented as unknown. Details are listed in the attached article, titled, cerebral protection during mitraclip implantation. 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
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key8920773
MDR Text Key155214537
Report Number2024168-2019-11053
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 literature
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK SGC03
Device Catalogue NumberUNK SGC03
Was Device Available for Evaluation? No
Date Returned to Manufacturer07/31/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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