Model Number H7493808015350 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/23/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 shaft break occurred.A 3.5mm x 15mm quantum¿ maverick¿ balloon catheter was selected for use.During unpacking, it was noted that the balloon shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The balloon was tightly folded.There was blood on the outside of the device and in between the folds of the balloon.The tip, inner/outer shafts and hypotube were microscopically inspected.Inspection revealed a kink in the hypotube, 71 cm from the strain relief and a fracture in the hypotube 75cm from the strain relief.The fracture faces oval, as if kinked prior to separation.Inspection found the rest of the device free of damage.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 shaft break occurred.A 3.5mm x 15mm quantum¿ maverick¿ balloon catheter was selected for use.During unpacking, it was noted that the balloon shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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