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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES

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ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES Back to Search Results
Catalog Number CDS0702-NT
Device Problems Break (1069); Material Separation (1562); Unstable (1667)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2023
Event Type  malfunction  
Event Description
This will be filed to report a material separation.It was reported that during device prep of a mitraclip procedure, the cap to the flush port on the delivery catheter handle would not screw on due to the threading.Subsequently, the device was exchanged and the procedure was completed without further reported complication.There was no clinically significant delay in the procedure and no patient involvement.The device was returned for analysis and a material separation was found.No additional information was provided.
 
Manufacturer Narrative
The reported broken dc handle flush port was confirmed during returned device analysis.The reported unstable cap could not be replicated in a testing environment due to the condition of the device (flush port was broken).Additionally, it was observed that the loctite fillet was not present on the area inside of the top flush port.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported dc handle flush port break resulting in unstable cap is due to missing loctite.The missing loctite is due to missed steps during manufacturing (man), as investigated in exception action.Corrective action will be implemented in the future to address this issue by improving the station layout and procedure.Abbott will continue to trend the performance of these devices.
 
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Brand Name
MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
Type of Device
MITRAL VALVE REPAIR DEVICES
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key17074759
MDR Text Key316759489
Report Number2135147-2023-02467
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/06/2023
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 Date08/08/2023
Device Catalogue NumberCDS0702-NT
Device Lot Number20809R1034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2023
Initial Date FDA Received06/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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