|
Catalog Number RBY4C1240 |
Device Problem
Kinked (1339)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/14/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2018-00533, 3005168196-2018-00534, 3005168196-2018-00535.The hospital disposed of the device.
|
|
Event Description
|
The patient was undergoing a coil embolization procedure in the right and left subclavian arteries using ruby coils.During the procedure, after advancing a ruby coil, the physician retracted it from the right subclavian artery because the ruby coil was the wrong size.However, upon removal from the lantern delivery microcatheter (lantern), the ruby coil became kinked.This same issue then occurred with a second ruby coil.The physician then attempted to place a ruby coil in the left subclavian artery, however the pusher assembly of the ruby coil became kinked upon insertion into a lantern; therefore, it was removed.This same issue then occurred with another ruby coil, and the ruby coil was removed.The procedure was then completed using additional ruby coils.There was no report of an adverse effect to the patient.
|
|
Search Alerts/Recalls
|
|
|