MAUDE Adverse Event Report: MEDTRONIC VASCULAR LAUNCHER GUIDING CATHETER 6F; CATHETER, PERCUTANEOUS

Model Number 0.071" EBU3.5

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2016

Event Type  malfunction  

Event Description

In the process of performing a stemi, dr.Requested a certain guide catheter.While flushing the guide for preparation, a nurse noticed several defects in the catheter.Catheter was removed from table and another one given.

• Brand Name: LAUNCHER GUIDING CATHETER 6F
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC VASCULAR; 37 a cherry hill drive; danvers MA 01923
• MDR Report Key: 5811613
• MDR Text Key: 50080114
• Report Number: 5811613
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/10/2018
• Device Model Number: 0.071" EBU3.5
• Device Catalogue Number: LA6EBU35
• Device Lot Number: 0008047258
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1