BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
|
Back to Search Results |
|
Model Number 24686 |
Device Problem
Material Rupture (1546)
|
Patient Problem
Hematoma (1884)
|
Event Date 01/29/2019 |
Event Type
Injury
|
Event Description
|
It was reported that balloon rupture and vessel hematoma occurred.The target lesion was located in a tortuous arteriovenous fistula in an upper limb.A 7.0 x 40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during first inflation at 24 atmospheres, the balloon rupture.The vessel was damaged and immediately formed hematoma.The physician used another of the same balloon to treat the hematoma and completed the procedure.No patient complications were reported and the patient's status was stable.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A microscopic examination identified a balloon longitudinal tear beginning at the proximal balloon bond and extending approximately 56mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 20 atmospheres.A visual and microscopic examination found no issues with the markerbands or tip of the device that could have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were noted with the device during analysis.
|
|
Event Description
|
It was reported that balloon rupture and vessel hematoma occurred.The target lesion was located in a tortuous arteriovenous fistula in an upper limb.A 7.0 x 40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during first inflation at 24 atmospheres, the balloon rupture.The vessel was damaged and immediately formed hematoma.The physician used another of the same balloon to treat the hematoma and completed the procedure.No patient complications were reported and the patient's status was stable.
|
|
Search Alerts/Recalls
|
|
|