MAUDE Adverse Event Report: MEDTRONIC PS MEDICAL, INC. EDM; INTRACEREBRAL INFUSION/DRAINAGE CATHETER, SHORT-TERM

Lot Number D73020

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 12/18/2017

Event Type  malfunction  

Event Description

Medical doctor anesthesiologist was pulling out catheter when she noticed tip had sheared off catheter.Possible user error.

• Brand Name: EDM
• Type of Device: INTRACEREBRAL INFUSION/DRAINAGE CATHETER, SHORT-TERM
• Manufacturer (Section D): MEDTRONIC PS MEDICAL, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 7302363
• MDR Text Key: 101176381
• Report Number: 7302363
• Device Sequence Number: 1
• Product Code: PCB
• 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: 02/20/2018,02/23/2018

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
• Device Operator: No Information
• Device Expiration Date: 11/30/2019
• Device Lot Number: D73020
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2018
• 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
• Patient Age: 85 YR