Model Number 1177-01 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/20/2024 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the severely calcified superficial femoral artery.A 6x200mm, 150cm ranger balloon catheter was advanced for dilation.During the procedure, the balloon burst before it was inflated to nominal burst pressure (nbp).The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
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Event Description
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It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the severely calcified superficial femoral artery.A 6x200mm, 150cm ranger balloon catheter was advanced for dilation.During the procedure, the balloon burst before it was inflated to nominal burst pressure (nbp).The procedure was completed with another of the same device.No complications were reported, and the patient was stable.It was further reported that the balloon rupture upon first inflation and was removed from the patient slowly and carefully.
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Manufacturer Narrative
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Device evaluated by mfr.: the ranger was returned for analysis.The returned device was attached to a boston scientific encore inflation unit and the balloon was inflated to its rated burst pressure with no leaks or issues noted.The markerbands and blades and tip section of the device were visually examined, and no issues were noted with the markerbands or tip of the device.A visual and tactile examination of the hypotube shaft found no issues with the shaft.
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Search Alerts/Recalls
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