Model Number H749390140 |
Device Problem
Hole In Material (1293)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 03/06/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that a hole was found on the catheter.During a percutaneous coronary intervention, the 90% stenosed target lesion was located in a moderately calcified and moderately tortuous middle left anterior descending coronary artery.An atlantis sr pro² imaging catheter was used in conjunction with a motor drive unit to view the lesion.During preparation, a hole was noticed on the connecting plastic portion of the imaging catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.
|
|
Manufacturer Narrative
|
Age at time of event: 18 years or older.(b)(4).
|
|
Manufacturer Narrative
|
Device returned to mfr: the device was returned for evaluation.Examination of the returned device revealed that the hub flaps appeared normal and a good click sound was heard during insertion into the mdu system.Fluid was leaking at the male/female luer connection was connected when the catheter was flushed.During image characterization testing in the roller coaster model, a good square image appeared in the system and the product performed within specification.No other issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
|
|
Event Description
|
It was reported that a hole was found on the catheter.During a percutaneous coronary intervention, the 90% stenosed target lesion was located in a moderately calcified and moderately tortuous middle left anterior descending coronary artery.An atlantis¿ sr pro² imaging catheter was used in conjunction with a motor drive unit to view the lesion.During preparation, a hole was noticed on the connecting plastic portion of the imaging catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.
|
|
Search Alerts/Recalls
|