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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 Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned and investigated. The sgc was noted to have a torn soft tip. 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 observed tear in the soft tip may be related to an issue related to procedural conditions (the open clip was pulled into the sgc) or post-procedural shipping and handling. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling. The clip delivery system has been filed under mfr report # 2024168-2017-07639.
 
Event Description
This is filed to report the soft tip tear. It was reported that the patient, with grade 3 functional mitral regurgitation (mr), underwent a mitraclip procedure. The clip delivery system (cds) was advanced into the patient anatomy, but during removal, could not be fully closed, so it was removed from the anatomy (see mfr report # 2024168-2017-07639) with the steerable guide catheter (sgc) as a single unit. There were no reported issues with the sgc; however, the device was returned and a soft tip tear was noted. 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 Key6908205
MDR Text Key88113948
Report Number2024168-2017-07903
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
Report Date 10/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/20/2018
Device Catalogue NumberSGC0302
Device Lot Number70419U213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
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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