Model Number H7493808012350 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2016 |
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 shaft break occurred.The target lesion was located in a coronary artery.A 3.5mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, upon introduction, the delivery shaft was fractured outside the patient.The procedure was completed with a different device and no patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter with mandrel and balloon protector.The balloon was tightly folded.There was contrast in the inflation lumen.The outer shaft, inner shaft, balloon and tip were microscopically examined.There was a hypotube kink 22cm from the hub.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.The reported shaft fracture/broken was not confirmed via product analysis.Because there was no evidence of any product quality deficiencies, it was considered likely that the kink was attributable to procedural factors.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
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Event Description
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It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.5mm x 12mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.However, upon introduction, the delivery shaft was fractured outside the patient.The procedure was completed with a different device and no patient complications were reported.
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Search Alerts/Recalls
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