MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	LA6JR35
Medical Device Problem Code	Device Expiration Issue (1216)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The launcher guide catheter was used approx 5 days past its expiry date.Patient is well.Device discarded.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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 Key: 6787898
• Report Number: 1220452-2017-00077
• Device Sequence Number: 13481266
• Product Code: DQY
• UDI-Device Identifier: 00613994817723
• UDI-Public: 00613994817723
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K021256
• 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,Followup
• Report Date (Section B): 10/19/2017

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 Date: 07/07/2017
• Device Catalogue Number: LA6JR35
• Device Lot Number: 0007643486
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 75