(b)(4).Conclusion: the prowler select plus microcatheter was not returned for analysis.Review of dhr for lot 17409255 that (b)(4) rejected unit (due to tight id) may be related to the reported complaint.However, the dhr review confirmed that the rejected unit was properly segregated and discarded.Controls are in place to detect such nonconformities.No other issues were noted that were considered potentially related to the reported complaint.The enterprise (lot 10507216) was not returned for analysis.(b)(4) reviewed the device history records relative to the manufacturing, inspecting and packaging of the above mentioned lot.The device history record review also included a review of the certificate of conformance received from specialty coatings systems and nitinol devices and components, along with (b)(4) internal receiving inspection records for the stents issued to the complaint lot.The history records indicate this product was final inspection tested at (b)(4) and was determined to be acceptable.The failure of the enterprise stents to be deployed through the prowler select plus microcatheter could not be confirmed without product return for analysis.The root cause of the event could not be determined based on the information provided.Device handling/procedural factors may have contributed to the event.There was no evidence of a manufacturing issue related to the event; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.This is 1 of 4 mdr reports being submitted for this complaint, with associated report numbers of 3008264254-2017-00037, 1226348-2017-00046, 1226348-2017-00047 and 3008264254-2017-00038.
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The contact from the facility reported that the enterprise stent (enc452212/10507216) could not be deployed through the prowler select plus microcatheter (606s255x/17409255.) the patient had a left internal carotid ophthalmic aneurysm.The physician withdrew the stent with the microcatheter after it could not be deployed.The physician used new enterprise stent (enc452212/10507216) and microcatheter (606s255x/ 17409255), but the stent did not deploy.The stent was exchanged with the microcatheter again to complete the procedure.Nothing unusual was noted with the system prior to use, and a continuous flush had been maintained through the catheter.It was verified that the introducer was fully seated and secured in the microcatheter hub.There were no kinks noted on the catheter, and the catheter had not been re-shaped.The catheter was placed distal to the target site prior to advancement of the device to the target site followed by withdrawal of the catheter to deploy the device.There was no report on the patient injury and no significant delay in the procedure.The devices were discarded by the customer.
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