MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 7F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	LA7RDCK
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
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 in a patient procedure.The product was sold to the account on consignment.Medtronic are responsible for monitoring product at the account.Short dated/expired products are controlled by doing monthly stock counts and removing short dated stock.The stock management department send monthly short dated stock lists.This product did not reflect on any of the rep's 2018 expired stock list as it was written off in 2017.Hospital staff placed this particular product in another theatre which is not where the rep's consignment stock is kept nor where the rep's direct clients do their procedures.Therefore, the rep could not find the product in the theatre which their consignment stock is kept.The rep also checked the hospital pharmacy and did not find the item, so it was written off in (b)(6) 2017.

• Brand Name: LAUNCHER 7F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8331030
• Report Number: 1220452-2019-00013
• Device Sequence Number: 13699524
• Product Code: DQY
• UDI-Device Identifier: 00613994832863
• UDI-Public: 00613994832863
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K022764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2017
• Device Catalogue Number: LA7RDCK
• Device Lot Number: 0007602200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1