Catalog Number 606S255X |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This is two of two initial mdr report being submitted for this complaint with the associated mfr# 1226348-2016-00129.(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.
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Event Description
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As reported by a health care professional, during the procedure, an enterprise stent was getting stuck at the distal end of the prowler select plus catheter (606s255x/17199571).The physician was not able to deploy the stent; the stent deployed in the catheter hub when the physician was resheathing the stent.The procedure was abandoned.It is unknown if the reported event caused any delays or adverse events.No difficulty was reported tracking the catheter to the target site or excessive torquing required prior to the introduction of the stent.An adequate continuous flush was maintained through the catheter.Procedure was endovascular coiling at the middle cerebral artery and the patient's vessels were reported to be of medium tortuousity; no further patient or procedure information was provided.Prowler select plus catheter is not available for return.
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Manufacturer Narrative
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This is two of two final mdr reports being submitted for this complaint with associated mfr report# 1226348-2016-00129.The reported event of obstruction of the prowler select plus catheter could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.
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Search Alerts/Recalls
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