Model Number M001BP50620B0 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).
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Event Description
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It was reported that the sheath became torn.The target lesion was located in the vein.A 2cm peripheral cutting balloon¿ was selected for use.During withdrawal, it was noted that the entire sheath became torn.The procedure was completed with this device.No patient complications were reported and the patient's condition was stable.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the balloon noted that the balloon was unfolded which indicates it had been subjected to positive pressure.The balloon was attached to an encore inflation unit and successfully inflated to its rate of burst pressure.No leaks or drops in pressure were noted.A microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination of the device identified no damage to the markerbands, tip or blades.All blades were present and fully bonded to the balloon material.No issue was observed with the tip, blades or markerbands of the device which could have contributed to the complaint incident.On analysis, a vacuum was applied and successfully advanced and withdrew the device from a 6fr boston scientific introducer sheath without any resistance or issues noted.No issues were noted that could have contributed to the complaint incident.A visual and tactile examination identified no damage or nay issues along the length of the device.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Event Description
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It was reported that the sheath became torn.The target lesion was located in the vein.A 2cm peripheral cutting balloon was selected for use.During withdrawal, it was noted that the entire sheath became torn.The procedure was completed with this device.No patient complications were reported and the patient's condition was stable.
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Search Alerts/Recalls
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