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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 Loose or Intermittent Connection (1371); Physical Property Issue (3008)
Patient Problem No Patient Involvement (2645)
Event Date 07/15/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
This is filed to report that the stopcock could not connect to the steerable guide catheter (sgc) flush port. If this were to recur when the device was in the anatomy, there is potential for an air leak which can cause or contribute to patient injury. It was reported that during device preparation of the sgc, it was not possible to connect the high pressure three way stopcock into the flush port of the sgc. Three stopcocks were attempted unsuccessfully. The flush port appeared different. Another sgc was used successfully in the procedure. There was no patient involvement or a clinically significant delay in procedure reported. There was no additional information provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device returned for analysis. The irregular appearance was confirmed due to a broken stopcock luer lodged inside the flush port. However, returned device analysis could not confirm the reported loose/intermittent connection. 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 reported loose/intermittent connection may be attributed to variation in the non-abbott stopcocks used at the account; however, this cannot be definitively confirmed. The irregular appearance was determined to be related to the observed broken stopcock luer in the flush port. It is likely that the stopcock luer broke off during attempts to thread the stopcock onto the device. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.
 
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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 Key5854972
MDR Text Key51869280
Report Number2024168-2016-05235
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 08/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2017
Device Catalogue NumberSGC01ST
Device Lot Number60330U142
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
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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