It was reported that during the procedure subject catheter was noted to have a hole in the sidewall.Issue was noticed when guidewire exited the subject catheter through the side.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No additional information provided.Update: the subject catheter was returned for analysis on (b)(6) 2020 and the catheter was examined and it was discovered that the reported event of catheter shaft hole/perforation was not confirmed; therefore, the event no longer meets the requirement of the reportable event for the device in question.The reportability changed from reportable to non-reportable as a reportability awareness date (b)(6) 2020.The reported event was not related to a serious public health threat, patient death, unanticipated or anticipated serious injury to the patient.
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The device was returned, and the reported lot number was confirmed from the hub of the device.During visual inspection, the subject catheter shaft was noted to crushed, kinked/bent and the catheter tip was damaged.The subject catheter hub was intact.During functional inspection, the subject catheter was flushed no leak was identified.A 0.0158" patency mandrel was advanced through the microcatheter without any issue.The reported defect was not confirmed during analysis; however, deformation was noted to the device.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It can be presumed that the catheter was damaged during the procedure as force may have been applied during removal from the packaging.Because this defect appears to be associated with handling of the product or portion of the product during the procedure/upon removal of the product from the packaging/preparation of the product prior to use, a probable cause of handling damage will be assigned to the as analyzed defect 'catheter shaft flat/crushed' and 'catheter kinked/bent' & 'catheter tip damaged'.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
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