B3: date of event ¿ estimated d4: the unique device identifier (udi) is unknown because the part number and lot number were not provided.The devices were not returned to abbott vascular for analysis.A review of the electronic lot history records (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed because the part/lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported inflation problem, deflation problem, and patient-device incompatibility.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Attachment: rpt2135004 rev b titled; post market clinical follow-up evaluation report peripheral dilatation catheter family please see attachment for complete details.As multiple devices were captured in the pmcf report, the other devices referenced in the pmcf are filed under separate report numbers.
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This is filed for the device issues: it was reported through a post market clinical follow up (pmcf) evaluation report identifying the armada 35 dilatation catheter that may be related to the following: adverse effects of vessel rupture/hemorrhagic event, dissection, perforation, hematoma, embolism, occlusion/abrupt closure, pseudoaneurysm, and device issues of inflation and deflation issues, and inability to post-dilate a stent.Details are listed in the attached pmcf, titled post market clinical follow-up evaluation report peripheral dilatation catheter family please see the attached post market clinical follow up evaluation report for specific information.
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