Model Number H7493808012350 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that shaft break.During unpacking of a 3.5mm x 12mm quantum¿ maverick¿ balloon catheter, it was noted that the 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 with contrast in the inflation lumen.The hub, hypotube, port/exit notch, inner/outer shaft were microscopically and tactile inspected.Inspection revealed numerous kinks in the hypotube.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
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Event Description
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It was reported that shaft break.During unpacking of a 3.5mm x 12mm quantum¿ maverick¿ balloon catheter, it was noted that the 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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