BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
|
Back to Search Results |
|
Model Number 24686 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/13/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The gladiator elite 12.0 x40, 75cm, 14 atm was retuned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was present in the balloon which is indicative of a leak.The rated burst pressure for this device is 14 atmospheres as per gladiator elite specification.The returned device was attached to an encore inflation unit and positive pressure was applied and liquid was observed to be leaking from a balloon pinhole located approximately 14mm proximally of the proximal marker band.An examination of the balloon material and proximal marker band identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination of the shaft identified multiple kinks along the length of the shaft.A visual examination found no issues or damage to the markerbands of the device.
|
|
Event Description
|
Reportable based on device analysis completed on 14oct2021.It was reported that balloon leak occurred.A 12.0 x40, 75cm gladiator elite balloon catheter was selected for use.However, during preparation the balloon leaked when testing it with water.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed a balloon pinhole.
|
|
Search Alerts/Recalls
|
|
|