MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM LUMBAR CATHETER BARIUM IMPREGNATED, 80 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	46419
Medical Device Problem Codes	Break (1069); Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received reported that leaving the distal part of the device within the patient did not cause or contribute to the patient¿s death.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that the lumbar drain was inserted in the context of an emergency thoracic endovascular aneurysm repair.According to the report, the patient was in a lateral position and awake during insertion.The insertion of the tuohy needle was straightforward and identification of being in the subarachnoid space was with free flowing cerebrospinal fluid (csf).It was stated that when the device and guidewire were preloaded to the tip of the drain and inserted through the tuohy needle, they encountered resistance.On withdrawing the device, it was noticed that the end sheared off leaving a distal part of the device within the patient.Reportedly, there was a consensus decision not to repeat the drain insertion but proceed with the case which led to a delay of 30-45 minutes.It was stated the procedure was successful under general anesthesia, and the patient was transferred and awake to the intensive care unit (icu) for neurological monitoring.Residual drain in csf was discussed, but no further investigation or actions were required as the patient was neurologically intact.However, the patient subsequently died from likely unrelated illness.Postmortem showed the patient having a hematoma retro dissection.
Additional Manufacturer Narrative
Additional information received reported that leaving the distal part of the device within the patient did not cause or contribute to the patient¿s death.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDM LUMBAR CATHETER BARIUM IMPREGNATED, 80 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6532124
• Report Number: 2021898-2017-00247
• Device Sequence Number: 18855766
• Product Code: JXG
• UDI-Device Identifier: 00613994806628
• UDI-Public: 00613994806628
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K862303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 46419
• Device Lot Number: E26917
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 07/10/2017; 07/10/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 08/08/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR