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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 Problems Difficult to Insert (1316); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The steerable guide catheter was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
This report is filed for the tear noted on the soft tip of the steerable guide catheter. A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the anatomy. It was reported that during a mitraclip procedure, the steerable guide catheter (sgc) was unable to be inserted into the femoral vein. The femoral vein was dilated again; however, the sgc soft tip had been damaged and ripped. Another sgc was used in replacement without reported issue. There were no adverse patient effects and there was no clinically significant delay. Two mitraclips were implanted and functional mitral regurgitation was reduced from grade 4 to grade 1. There was no additional information provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device returned for analysis and the reported steerable guide catheter (sgc) torn soft tip was not confirmed, but was noted to be damaged (kinked). The reported failure to advance was unable to be tested as it related to the anatomy. A review of the lot history record revealed no manufacturing nonconformities. Additionally, a review of the complaint history identified no other incidents reported from this lot. All available information was investigated and the reported failure to advance resulting in the soft tip damage appears to be related to user technique/procedural conditions. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the initial medwatch report, the additional information was received: the steerable guide catheter (sgc) was unable to insert into the vena cava. Reportedly, a lot of push was required; however the sgc soft tip had then become damaged and ripped.
 
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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 Key6224205
MDR Text Key64172127
Report Number2024168-2017-00093
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/12/2017
Device Catalogue NumberSGC0302
Device Lot Number60912U150
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/03/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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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