MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 5F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	LA5JR40
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2016
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 is reported that an expired launcher device was used during a procedure.No patient injury reported.The products were not expired when the distributor sent the item to the hospital.It was confirmed that the device was expired by the usage report provided by the medtronic rep and confirmed with the cath lab.The process for controlling short dated/expired product at the account is aging monitoring of expiration dates and pull-out of the near expiry items before 30 days from the expiration date.Products are managed by the hospital through consignment and current process is inventory being monitored by the distributor and medtronic.

• Brand Name: LAUNCHER 5F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7973384
• Report Number: 1220452-2018-00122
• Device Sequence Number: 16555355
• Product Code: DQY
• UDI-Device Identifier: 00613994782687
• UDI-Public: 00613994782687
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K132673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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 Date: 03/30/2016
• Device Catalogue Number: LA5JR40
• Device Lot Number: 0007092710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1