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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tissue Damage (2104)
Event Date 01/02/2014
Event Type  Injury  
Manufacturer Narrative
(udi#): in the absence of a reported part number, the udi number cannot be calculated. The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Article titled, anesthesia management for mitraclip device implantation.
 
Event Description
This will be filed to report tissue damage during use of the steerable guide catheter (sgc). It was reported through a research article identifying the mitraclip devices which may be related to tissue damage with steerable guide catheter (sgc). Details are listed in the article, titled anesthesia management for mitraclip device 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 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key11096069
MDR Text Key224401167
Report Number2024168-2020-11014
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSN
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 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received01/07/2021
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

Patient Treatment Data
Date Received: 12/30/2020 Patient Sequence Number: 1
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