BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
|
Back to Search Results |
|
Model Number 24686 |
Device Problem
Material Rupture (1546)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/06/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that balloon rupture occurred.The target lesion was located in the right saphenous vein.A 12.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.However, during procedure at 14 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
|
|
Event Description
|
It was reported that balloon rupture occurred.The target lesion was located in the right saphenous vein.A 12.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.However, during procedure at 14 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.It was further reported that the target lesion was mildly tortuous and mildly calcified.The balloon was inflated once and was removed completely from the patient's body.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.: gladiator 12 x 40, 14atm, 75cm was returned or analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 61 mm in length and extended from a position 17 mm proximal of the proximal markerband to 13 mm distal of the distal markerband.An examination of the balloon material and markerbands 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 found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified during the product analysis.
|
|
Event Description
|
It was reported that balloon rupture occurred.The target lesion was located in the right saphenous vein.A 12.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.However, during procedure at 14 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.It was further reported that the target lesion was mildly tortuous and mildly calcified.The balloon was inflated once and was removed completely from the patient's body.
|
|
Search Alerts/Recalls
|
|
|