|
Model Number H80222782001A0 |
Device Problem
Entrapment of Device (1212)
|
Patient Problems
Chest Pain (1776); Dyspnea (1816)
|
Event Date 08/27/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
Same case as mdr id 2134265-2015-06397, 2134265-2015-06398.It was reported that the rota burr was stuck on the rotawire and patient experienced chest pain and dyspnea.A 330cm rotawire, rotalink¿ advancer and 1.50mm rotalink¿ burr were selected to treat the severely calcified target lesion located in the mid left anterior descending artery (lad).During the procedure, inside patient, it was noted that the rota burr was stuck with the rota wire and the advancer could not be moved in and out.The physician was able to remove the burr and the wire together as a unit after several attempts.However, due to the long time of procedure, the patient experienced chest pain and difficulty breathing.The procedure was completed with a different device.No further patient complications were reported and the patient's condition is stable.
|
|
Manufacturer Narrative
|
(b)(4).Device evaluated by mfr.: the complaint unit was returned connected to the catheter.A visual examination of the complaint unit was carried out and no issues were noted.The advancer knob was locked upon return in a backward position; it was loosened and advanced in order to inspect the handshake connection.The handshake connection was inspected and no damage was noted.A handshake connection test and a tug test was attempted to examine the integrity of the connection.No issues were noted.The complaint unit was wet tested.The complaint rotablator system did not reach any speed.The device was dismantled and a melted ultem was evident.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the dfu states: ¿never operate the rotablator advancer without saline infusion.Flowing saline is essential for cooling and lubricating the working parts of the advancer.Operation of the advancer without proper saline infusion may result in permanent damage to the advancer.¿ (b)(4).
|
|
Event Description
|
Same case as mdr id 2134265-2015-06397, 2134265-2015-06398.It was reported that the rota burr was stuck on the rotawire and patient experienced chest pain and dyspnea.A 330cm rotawire, rotalink¿ advancer and 1.50mm rotalink¿ burr were selected to treat the severely calcified target lesion located in the mid left anterior descending artery (lad).During the procedure, inside patient, it was noted that the rota burr was stuck with the rota wire and the advancer could not be moved in and out.The physician was able to remove the burr and the wire together as a unit after several attempts.However, due to the long time of procedure, the patient experienced chest pain and difficulty breathing.The procedure was completed with a different device.No further patient complications were reported and the patient's condition is stable.
|
|
Search Alerts/Recalls
|
|
|