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

Catalog Number 46419

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/25/2017

Event Type  Injury  

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 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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDM LUMBAR CATHETER BARIUM IMPREGNATED, 80 CM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis,mn, CA 55432 ; 7635260594
• MDR Report Key: 6532124
• MDR Text Key: 74006823
• Report Number: 2021898-2017-00247
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00613994806628
• UDI-Public: 00613994806628
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K862303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 46419
• Device Lot Number: E26917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR