MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY LUMBAR CATHETER KIT, OPEN TIP, 84 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 44406

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/28/2017

Event Type  Injury  

Event Description

It was reported that while the lumbar catheter was inserted and was directed towards the spinal canal, it seem that the tuohy needle tip and the catheter tip were unable to be advanced due to being caught.Only the catheter was attempted to be removed, although the tuohy needle should have been removed as well.Then, the catheter fractured and a piece of it remained in the patient body.

Manufacturer Narrative

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

Event Description

Additional information received reported that the physician determined that the broken piece left inside the patient did not pose a risk to the patient and would not be likely to cause or contribute to a death or serious injury.

• Brand Name: LUMBAR CATHETER KIT, OPEN TIP, 84 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 55432 ; 7635260594
• MDR Report Key: 6979701
• MDR Text Key: 90324454
• Report Number: 2021898-2017-00542
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091312
• 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
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44406
• Device Catalogue Number: 44406
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2017
• 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