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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 SGC0301
Device Problems Leak/Splash (1354); Physical Property Issue (3008)
Patient Problem No Patient Involvement (2645)
Event Date 04/18/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was returned. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
This is filed to report the steerable guide catheter (sgc) leak. It was reported that during preparation of the sgc, it failed to hold column during preparation [leak]. It was noticed at the distal end of the shaft some glue was missing. Air was entering the guide coming up from handle towards valve. The sgc was not used and another sgc was used successfully in the procedure. There was no patient involvement and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was returned. The results of the returned device analysis confirmed the reported steerable guide catheter (sgc) leak and indicated that a hole on one of the lumens at the skive resulted in the leak. The reported irregular appearance/physical property issue was not confirmed, as the glue fillet was sufficiently present around the circumference of the hypotube at the distal end. A review of the lot history record revealed no manufacturing nonconformities reported to this lot that would have contributed to this reported event. Additionally, a review of the complaint history identified no similar incidents reported from this lot. Based on the information reviewed, the irregular appearance appears to be related to the user perception. The reported leak appears to be related to the observed hole on one of the lumens at the skive. The issue is being addressed per internal operating procedures. Abbott vascular (av) will continue to trend the performance of these devices.
 
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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 Key7496492
MDR Text Key107716905
Report Number2024168-2018-03393
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/13/2018
Device Catalogue NumberSGC0301
Device Lot Number71212U217
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2017
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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