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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

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AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER Back to Search Results
Catalog Number SGC0302
Device Problem Device Damaged by Another Device (2915)
Patient Problem Cardiac Arrest (1762)
Event Date 11/30/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The customer reported the sgc was discarded. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
This is filed to report cardiac arrest. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. One clip was implanted, reducing the mr to 1-2. During removal of the steerable guide catheter (sgc), the patient suffered a cardiac arrest. After removal of the sgc, it was noted that one of the pacemaker electrodes was moved out. In the physicians opinion, the manipulation of the sgc and heart morphology may have contributed to the cardiac arrest. The patient was stabilized with an electro-catheter and will remain hospitalized awaiting another interventional procedure to replace the electro catheter. One clip was implanted, reducing mr to 1-2. No additional information was provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceSTEERABLE GUIDE CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
MENLO PARK, CA REG# 3005070406
abbott vascular
26531 ynez rd.
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key8170551
MDR Text Key130533818
Report Number2024168-2018-09764
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/26/2019
Device Catalogue NumberSGC0302
Device Lot Number80925U257
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 Received02/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/17/2018 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP
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