Model Number M001PCB6020900 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/30/2015 |
Event Type
malfunction
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Event Description
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It was reported that a cutting balloon blade was partially lifted.A 6.00mm x 2.00cm x 90 cm peripheral cutting balloon® was selected and advanced to treat the target lesion.During the procedure, it was noted that a piece of metal was sticking out of the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.A visual examination noted that approximately 4mm of the proximal end of one blade had lifted from the balloon's proximal body; however, the blade pad was still intact.The remaining blades were fully bonded to the balloon and no damage was noted to the other blades.A visual and microscopic examination observed no damage to the tip.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.The returned device was attached to an encore inflation unit.Positive pressure was applied.No leak was noted.The balloon was inflated to its rated burst pressure of 10 atmospheres.The balloon inflated and deflated successfully.The encore inflation unit was verified before and after use using a calibrated pressure gauge.No kinks or damage were noticed along the shaft of the device.No other issues were noted during analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Event Description
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It was reported that a cutting balloon blade was partially lifted.A 6.00mm x 2.00cm x 90 cm peripheral cutting balloon® was selected and advanced to treat the target lesion.During the procedure, it was noted that a piece of metal was sticking out of the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
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Search Alerts/Recalls
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