Model Number 105650-001 |
Device Problem
Sticking (1597)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that the foot pedal was sticking.An angiojet® ultra system console was selected for a thrombectomy procedure.During the procedure inside the patient, the foot switch was sticking.There was no debris that may cause sticking on the pedal, no physical damage to the foot pedal, and the foot pedal was connected securely.The procedure was completed with this device.There were no patient complications and the patient was fine.
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Manufacturer Narrative
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Device evaluated by mfr.:the angiojet assembly foot switch cable was received in good condition with no physical damages observed.The angiojet ultra system console and catheter were not returned for evaluation.The foot switch cable was installed into a pm angiojet and tested and passed test steps.No prime stopping and sticking on all switch positional activation during the testing.A service history review was performed and nothing was found to indicate a possible service-related cause for the complaint.The most probable root cause of the reported difficulty is a supplier design constraint of the product.(b)(4).
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Event Description
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It was reported that the foot pedal was sticking.An angiojet ultra system console was selected for a thrombectomy procedure.During the procedure inside the patient, the foot switch was sticking.There was no debris that may cause sticking on the pedal, no physical damage to the foot pedal, and the foot pedal was connected securely.The procedure was completed with this device.There were no patient complications and the patient was fine.
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Search Alerts/Recalls
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