MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM; EXTERNAL CSF DIVERSION

Catalog Number 46419

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 05/07/2018

Event Type  Injury  

Event Description

During the insertion of a lumbar drain, lumbar catheter broke off in pt.

• Brand Name: EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM
• Type of Device: EXTERNAL CSF DIVERSION
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 7525437
• MDR Text Key: 108805227
• Report Number: MW5077300
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/15/2018

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: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 46419
• Device Lot Number: E45940
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR