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

Catalog Number LA6JL35

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

Event Type  malfunction  

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 Description

A launcher guide catheter was used in a patient beyond it's expiration date.The guide catheter was used approximately 6 weeks post expiration date.No patient injury reported.

Manufacturer Narrative

Notified date is (b)(6) 2016.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6189789
• MDR Text Key: 62852592
• Report Number: 1220452-2016-00087
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2016
• Device Catalogue Number: LA6JL35
• Device Lot Number: 0007319934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2017
• Date Device Manufactured: 10/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1