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 03/04/2024 |
Event Type
malfunction
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Event Description
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It was reported that balloon burst occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 6x200mm, 150cm ranger dcb was advanced for dilation.During the procedure, the balloon burst upon second inflation.The procedure was completed with another of the same device.No complications were reported.
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Event Description
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It was reported that balloon burst occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 6x200mm, 150cm ranger dcb was advanced for dilation.During the procedure, the balloon burst upon second inflation.The procedure was completed with another of the same device.No complications were reported.
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Manufacturer Narrative
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A ranger device was received for analysis.The returned device was attached to a boston scientific encore inflation unit and the balloon was inflated to its rated burst pressure of 14 atm 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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