(b)(4).Device evaluated by manufacturer: a visual examination identified a kink 35cm distal of the strain relief.Functional testing was performed and the device ran within the normal range, without any leaks from the hub; however, the shaft leaked at the kink.The shaft was microscopically examined and it was noticed that there was a hole in the shaft at the same location as the kink (35cm distal of the strain relief).Because there was no evidence of any product quality deficiencies, it was considered likely that the kink and hole in the shaft were attributable to the handling of the device.The overall investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
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Reportable based on the product analysis completed on april 26, 2018.It was reported, during preparation for use of an angiojet solent omni thrombectomy catheter, the hub was cracked and leaked during priming.The device was never introduced to the patient.No patient complaints were reported.However, the returned product analysis revealed a hole in the shaft.
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