Device product
13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
Z-2200-2012
Product summary
- Firm
- Nico Corp.
- Event
- Event 62588
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 devices (4 boxes, 5 devices per box)
- Official record key
device-enforcement:Z-2200-2012
Official wording
Reason: BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.
Code information: REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)
Distribution pattern: Worldwide Distribution - USA including MI and Canada
Derived failure modes
-
Labeling or packaging
mislabeled