MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM LUMBAR CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 46419

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

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

Event Date 06/06/2018

Event Type  malfunction  

Event Description

Lumbar drain was being placed by dr.In interventional radiology.During the placement of the catheter, it broke off inside the patient during the adjustment of it.The separation (breakage) of the catheter happened just below the surface tissue of the back (maybe an inch?).Dr.1 attempted to retrieve it but was unable to.Being dr.2's patient, dr.1 consulted the situation with him and dr.2 and np proceeded to come to the biplane and help retrieve it and were successful.Every part of the catheter was retrieved and nothing was left in the patient.

• Brand Name: EDM LUMBAR CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7637353
• MDR Text Key: 112315593
• Report Number: 7637353
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00613994806628
• UDI-Public: (01)00613994806628(17)230228(10)E46362
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46419
• Device Catalogue Number: 46419
• Device Lot Number: E46362
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2018
• Event Location: Other
• Date Report to Manufacturer: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9125 DA