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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
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/14/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the delivery catheter's valve was pushed up into the catheter while attempting to insert the dilator.When attempting to place the valve back into position, the valve was pulled back out too far and was reportedly unsecure.The catheter was not used.No patient complications have been reported as a result of this event.
 
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Brand Name
DEFLECT
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
IE  
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10105222
MDR Text Key193365248
Report Number9612164-2020-02035
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/01/2020
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
Device Operator Health Professional
Device Model NumberC315HIS02
Device Catalogue NumberC315HIS02
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/14/2020
Initial Date FDA Received06/01/2020
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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