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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN COMMAND; CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND ATTAIN COMMAND; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 6250V-EH
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the implant procedure and prior to use with the patient, a small fiber was observed at the hub at the delivery catheter.The scrub nurse noted the fiber looked like a hair; the catheter was not utilized and replaced.No patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN COMMAND
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9481867
MDR Text Key182911758
Report Number9612164-2019-05204
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00643169142886
UDI-Public00643169142886
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/17/2019
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 Date12/17/2020
Device Model Number6250V-EH
Device Catalogue Number6250V-EH
Device Lot Number0009793343
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2019
Initial Date FDA Received12/17/2019
Date Device Manufactured06/19/2019
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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