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 for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The investigation was unable to determine a conclusive cause for the reported inflation issue, deflation issue 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.As multiple devices were captured in the pmcf report, the other devices referenced in the pmcf are filed under separate report numbers.
|
It was reported through a post market clinical follow up (pmcf) evaluation report identifying the armada 14 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.
|