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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP XTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

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AV-TEMECULA-CT MITRACLIP XTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM Back to Search Results
Catalog Number CDS0602-XTR
Device Problems Leak/Splash (1354); Unstable (1667); Material Protrusion/Extrusion (2979)
Patient Problem No Patient Involvement (2645)
Event Date 11/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
 
Event Description
This report is filed as a leak was noted at the gripper lever cap and a small part of red gripper line was outside the lever thread.It was reported that during clip delivery system preparation, a leak was observed at the gripper lever cap.The gripper lever cap was completely closed; however, a small part of the red gripper line cover was observed outside the lever thread.The device was set aside and was not used.There was no patient involvement.No additional information was provided regarding this device issue.
 
Manufacturer Narrative
Device codes: 2979 labeled.Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents for the reported issues.In this case, the device was not returned for evaluation.However, due to the reported information that a leak was observed at the gripper lever cap and the polyimide tubing was observed to be outside the lever thread, this failure mode appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
 
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Brand Name
MITRACLIP XTR DELIVERY SYSTEM
Type of Device
MITRACLIP DELIVERY SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key8126052
MDR Text Key129155596
Report Number2024168-2018-09230
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
PMA/PMN Number
P100009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/23/2019
Device Catalogue NumberCDS0602-XTR
Device Lot Number80822U363
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/12/2018
Initial Date FDA Received12/03/2018
Supplement Dates Manufacturer Received02/28/2019
Supplement Dates FDA Received03/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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