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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS
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MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number LA6JL30
Medical Device Problem Code Device Expiration Issue (1216)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/09/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The launcher guide catheter was removed from packaging per ifu with no issues noted.After catheter had been used, it was noticed that it was expired for 8 days.The event did not lead to or extend patient hospitalization.No injury reported.The hospital didn't keep the catheter.
 
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Brand Name
LAUNCHER 6F GUIDE CATHETER
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
MDR Report Key6556745
Report Number1220452-2017-00037
Device Sequence Number134138
Product Code DQY
UDI-Device Identifier00613994818126
UDI-Public00613994818126
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K021256
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 02/13/2017
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 Date02/01/2017
Device Catalogue NumberLA6JL30
Device Lot Number0007453931
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/13/2017
Initial Report FDA Received Date05/10/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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