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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 SGC0101
Device Problems Loose or Intermittent Connection (1371); Physical Property Issue (3008)
Patient Problem No Patient Involvement (2645)
Event Date 01/25/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: (b)(4). The complaint device was returned for evaluation. The investigation indicated that the reported loose connection between the stopcock and luer was confirmed, and appears to be related to the observed cracks on the flush port threads; however, a definitive cause for the observed cracks could not be determined. Additionally, the reported irregular appearance could not be confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history no other incidents reported from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This report is filed for the inability to connect the flush port to the stopcock. This could result in a leak during the procedure, which has the potential to cause or contribute to patient injury. It was reported that the stopcock would not stay connected to the flush port on the steerable guide catheter (sgc) during device preparation. There was no patient involvement. Another sgc was used with the same stopcock to complete the procedure without further incident. There was no clinically significant delay in the procedure. 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 Key5445084
MDR Text Key38748424
Report Number2024168-2016-00960
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 02/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2016
Device Catalogue NumberSGC0101
Device Lot Number51105U128
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2015
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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