BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number 24628 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that a balloon rupture occurred.The target lesion was located in the severely stenosed arteriovenous fistula.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at less working pressure when inflated for a few seconds.The device was simply pulled out from the patient's body.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.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 3mm distal of the proximal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.A visual examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.This concludes the product analysis.
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Event Description
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It was reported that a balloon rupture occurred.The target lesion was located in the severely stenosed arteriovenous fistula.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at less working pressure when inflated for a few seconds.The device was simply pulled out from the patient's body.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
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