BOSTON SCIENTIFIC CORPORATION ATHLETIS PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 39347-080450 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2021 |
Event Type
malfunction
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Event Description
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It was reported the balloon ruptured.An 8.0mm x 40mm x 50cm athletis balloon catheter was used to treat a previously placed wallstent in the cephalic vein that was 75% stenosed, moderately tortuous, and mildly calcified.The athletis balloon was advanced to the target lesion, inflated to 12atm and then ruptured.The damage was noted to be the shape of a pinhole.The procedure was completed with another athletis balloon.The patient was reported in good condition.
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Manufacturer Narrative
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Device evaluated by manufacturer: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 31 atmospheres as per 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 5mm distal from the distal markerband.A visual and tactile examination identified no kinks or damage to the shaft or tip which may have potentially contributed to the complaint incident.
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Event Description
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It was reported the balloon ruptured.An 8.0mm x 40mm x 50cm athletis balloon catheter was used to treat a previously placed wallstent in the cephalic vein that was 75% stenosed, moderately tortuous, and mildly calcified.The athletis balloon was advanced to the target lesion, inflated to 12atm, ruptured, and was noted to be the shape of a pinhole.The procedure was completed with another athletis balloon.The patient was reported in good condition.
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