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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND DEFLECT; CATHETER, PERCUTANEOUS
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MEDTRONIC IRELAND DEFLECT; CATHETER, PERCUTANEOUS Back to Search Results
Model Number C315HIS02
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/07/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that when peeling the sheath during the implant procedure, the catheter valve was not cut correctly, causing the electrode to ¿tangle¿ in the valve, resulting in the sheath becoming closer to the distal part of the electrode.The physician used a mosquito tool to peel and remove the valve.No patient complications have been reported as a result of this event.
 
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Brand Name
DEFLECT
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
MDR Report Key10704122
Report Number9612164-2020-04011
Device Sequence Number14316908
Product Code DQY
UDI-Device Identifier00613994749925
UDI-Public00613994749925
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K101885
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/20/2020
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
Operator of Device Health Professional
Device Expiration Date07/01/2022
Device Model NumberC315HIS02
Device Catalogue NumberC315HIS02
Device Lot Number0010296242
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/07/2020
Initial Report FDA Received Date10/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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