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Model Number H74939207120470 |
Device Problem
Hole In Material (1293)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
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Event Description
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It was reported that balloon pinhole occurred.A 12.0 x40 75cm gladiator¿ balloon catheter was advanced for dilatation.However, upon inflation, it was noted that the balloon had a hole.The procedure was completed with a different device.No patient complications were reported.
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Search Alerts/Recalls
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