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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 Date 03/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 13mm proximal to the proximal end of the proximal marker band.No issues were identified with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination found no issues with the markerbands or tip of the device that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft of the device that could have contributed to the complaint incident.No other issues were noted with the device during analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design and 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 balloon had a pinhole.The target lesion was located in a vessel in the left arm.A 12.0 x40 75cm gladiator¿ balloon catheter was advanced for dilation.However, contrast leakage was observed from the beginning of the initial inflation and there was a hole noted on the balloon.The device was easily removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
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Search Alerts/Recalls
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