Model Number M001151050 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/10/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: (b)(6) or older.(b)(4).
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Event Description
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It was reported that foreign material was noted on the device.The target lesion was located at the shunt limb.An encore balloon catheter inflation device was selected for use.During the procedure, when trying to inflate the unspecified balloon, a white, paint like stain was noted in the inner catheter of the indeflator.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: the device was returned for analysis.A visual inspection of the device was performed and revealed a white stain on the side of the device, the stain was noted to be on the inside of the clear housing and on the outside of the barrel.The stain did not obstruct the graduation marks in the barrel.The adhesive stain is consistent with the application of excess adhesive.There is no adverse effect on the functionality on the encore device.Product meets specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is user preference issue as the product met specification but the user was reportedly dissatisfied with the function, performance, or appearance of the product.(b)(4).
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Event Description
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It was reported that foreign material was noted on the device.The target lesion was located at the shunt limb.An encore balloon catheter inflation device was selected for use.During the procedure, when trying to inflate the unspecified balloon, a white, paint like stain was noted in the inner catheter of the indeflator.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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