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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 SGC01ST
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The first clip delivery system referenced is filed under a separate medwatch mfr number. The steerable guide catheter was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
This report is filed for the difficult device removal. It was reported that the mitraclip was successfully implanted; however, resistance was met during removal of the clip delivery system (cds) through the steerable guide catheter (sgc). The cds was successfully removed from the sgc using an abnormally large amount of force. Another clip was attempted, but met resistance during advancement in the sgc. Both devices were removed. A second mitraclip was successfully implanted using another sgc. Mitral regurgitation was reduced from 3 to 1-2. There were no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: (b)(4). The results of the returned device analysis confirmed the difficulty to insert the clip delivery system (cds) into the steerable guiding catheter (sgc) due to a misaligned valve and guide keyway. A review of the lot history record revealed no non-conformances issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified one other incident reported from this lot. Based on an expanded investigation, a product issue related misalignment was noted. Further assessment of this issue per site operating procedures is being performed. Corrective and preventative actions will be addressed per internal governing procedures. The performance of these devices will continue to be monitored.
 
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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 Key5436904
MDR Text Key38641087
Report Number2024168-2016-00874
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K112239
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 03/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2016
Device Catalogue NumberSGC01ST
Device Lot Number51015U218
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
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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