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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SELECTSITE; CATHETER, PERCUTANEOUS
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MEDTRONIC IRELAND SELECTSITE; CATHETER, PERCUTANEOUS Back to Search Results
Model Number C304-HIS
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/03/2020
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 an implant procedure while slitting the delivery catheter, the slitter got caught on a "metal ring" approximately two inches from the distal tip of the catheter.The catheter was removed.No patient complications have been reported as a result of this event.
 
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Brand Name
SELECTSITE
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
MDR Report Key9623138
Report Number9612164-2020-00391
Device Sequence Number10908995
Product Code DQY
UDI-Device Identifier00763000147006
UDI-Public00763000147006
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K183493
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/23/2020
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 Date06/17/2021
Device Model NumberC304-HIS
Device Catalogue NumberC304-HIS
Device Lot Number0009791363
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/03/2020
Initial Report FDA Received Date01/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age81 YR
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