BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24686 |
Device Problems
Leak/Splash (1354); Material Rupture (1546)
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Patient Problem
Hematoma (1884)
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Event Date 06/05/2020 |
Event Type
Injury
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Event Description
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It was reported that balloon pinhole occurred and the patient developed a hematoma.The target lesion was located in an upper arm vessel.A 5.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during the first inflation at 6 atmospheres, it was noticed that the balloon was leaking fluid.The device was removed and tested for pressure.It was found that there was a hole in the balloon.The long operation time resulted in the patient developing a hematoma in the upper arm.The patient was transferred to a different hospital and sent to surgery.No further patient complications were reported.
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Manufacturer Narrative
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Device evaluation by mfr: gladiator device - 5x40x40cm, 24atm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 1mm proximal of the proximal 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 of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination identified no issues or damage to the tip of the device.No issues were identified during the product analysis.
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Event Description
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It was reported that balloon pinhole occurred and the patient developed a hematoma.The target lesion was located in an upper arm vessel.A 5.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during the first inflation at 6 atmospheres, it was noticed that the balloon was leaking fluid.The device was removed and tested for pressure.It was found that there was a hole in the balloon.The long operation time resulted in the patient developing a hematoma in the upper arm.The patient was transferred to a different hospital and sent to surgery.No further patient complications were reported.
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