Model Number H965SCH505160 |
Device Problem
Contamination (1120)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/09/2014 |
Event Type
malfunction
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Event Description
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It was reported that balloon contamination occurred.They were unpacking the 8.0-40, 80 wanda¿ balloon to prepare for a percutaneous transluminal angioplasty (pta).While unpacking the device, it "jumped" out of the package and contacted an unsterile surface.The physician completed the procedure with another of the same device.There were no patient complications.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Device evaluated by mfr: received for analysis was the device without any packaging.The balloon protector was received placed over the balloon.There was no evidence of any device use.The balloon protector was withdrawn and an examination of the balloon found no issues.No kinks or damage was noted along the entire length of the shaft.An examination of the hub section of the device identified no anomalies which could potentially have contributed to the complaint incident.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
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Event Description
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It was reported that balloon contamination occurred.They were unpacking the 8.0-40, 80 wanda¿ balloon to prepare for a percutaneous transluminal angioplasty (pta).While unpacking the device, it "jumped" out of the package and contacted an unsterile surface.The physician completed the procedure with another of the same device.There were no patient complications.This product is only ous approved but it is similar to an approved us device.
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Search Alerts/Recalls
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