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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 Material Integrity Problem (2978)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/07/2020
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 during use the delivery catheter could not be cut "normally".The delivery catheter was removed and the procedure was successfully completed with a different delivery catheter.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
EI 
MDR Report Key11013761
Report Number9612164-2020-04931
Device Sequence Number753615
Product Code DQY
UDI-Device Identifier00613994749925
UDI-Public00613994749925
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K101885
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/15/2020
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 Date08/21/2022
Device Model NumberC315HIS02
Device Catalogue NumberC315HIS02
Device Lot Number0010350384
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/07/2020
Initial Report FDA Received Date12/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age39 YR
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