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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 SGC0302
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: the steerable guiding catheter (sgc) was returned and investigated. A torn hemostasis valve was observed during returned device analysis. 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 a definitive cause for the tear in the hemostasis valve could not be determined. It is likely that while removing the clip delivery system (cds), damage may have occurred resulting in the formation of the tear; however, this cannot be determined. Based on the information reported, there is no indication of a product quality issue with respect to manufacture, design or labeling. The clip delivery system is filed under mfr report #2024168-2016-09157.
 
Event Description
This is filed to report that returned device analysis found that the hemostasis valve of the steerable guiding catheter (sgc) was torn, and if were to reoccur, has the potential to cause or contribute to patient injury. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. There was a large jet located along the a2-p2 and a1-p1 scallop. The clip delivery system (cds) was advanced to the leaflets and the mr was reduced to 3+ with grasping. Deployment steps were started, but after the gripper line was retracted a few millimeters, it could not be properly removed. It was confirmed that the gripper line moved freely during the gripper line removability test. Troubleshooting maneuvers were performed without success. The cds was removed, leaving the gripper line in place. After removing the cds, the two ends of the gripper line were visible outside the hemostatic valve of the steerable guiding catheter (sgc). Another attempt was made to remove the gripper line, but was unsuccessful. The sgc was then removed, leaving the gripper line in place attached to the deployed clip. A new sgc was advanced and a second clip was deployed lateral to the first clip, reducing the mr to 1-2. The patient was confirmed to be stable post procedure. The sgc was returned, and it was found that the hemostasis valve was torn. 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 Key6274829
MDR Text Key65907607
Report Number2024168-2017-00660
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K161985
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
Report Date 01/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/09/2017
Device Catalogue NumberSGC0302
Device Lot Number60908U117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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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