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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 Detachment Of Device Component (1104); Out-Of-Box Failure (2311); Physical Property Issue (3008)
Patient Problem No Patient Involvement (2645)
Event Date 01/05/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The steerable guide catheter was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report that during unpackaging of the steerable guide catheter, the o-ring was potentially detached; o-ring detachment may not always be detectable and, if used in the anatomy, has the potential to cause a leak and introduction of air in the patient. It was reported that when the steerable guiding catheter (sgc) package was opened, it was noted that the side valve on the dilator was damaged. The screw cap was loose in the package, and there was a small plastic ring loose. The sgc was not used and there was no patient involvement. There was no clinically significant delay in the intended procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: (b)(4). The steerable guide catheter (sgc)was returned without evidence of usage. The dilator, rotating hemostatic valve (rhv) cap and teflon o-ring were not returned. A proxy cap and o-ring were used to test the device with no leaking observed. Based on the results of the investigation, it was determined the detached rhv cap, resulting in a detached o-ring was a result of handling during device transit. A review of the complaint handling database found no other similar incidents from this lot for detachment. The lot history record was reviewed and identified no manufacturing nonconformities that were related to detachment. 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 Key5404824
MDR Text Key37716559
Report Number2024168-2016-00582
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUK
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 03/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2016
Device Catalogue NumberSGC01ST
Device Lot Number50903U130
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
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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