Result: the 5maxace catheter is fractured approximately 7.0, 17.0, and 20.0 cm from the hub.The break sites show material deformation and stretching.Conclusion: the device was returned for analysis and has been evaluated.The complaint indicates during the second attempt to introduce 5maxace catheter into the patient, the catheter kinked and broke in two locations.Evaluation of the returned catheter confirmed fractures in the catheter shaft in three locations in the proximal shaft of the device.These fractures showed evidence of material deformation and stretching of the material.The cause of these fractures is unknown.Damage such as this usually occurs when devices are advanced or retracted with force in excess of the tensile strength of the material.The device was functional prior to the second attempt to re-insert into the patient during the procedure.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a thrombectomy procedure using the penumbra system 5max ace reperfusion catheter.During the procedure, the physician introduced the 5max ace catheter for a second time after being partially successful in the first attempt.While inserting the 5 max ace catheter, it was kinked and subsequently broke at two positions.The physician used another 5max ace catheter to complete the procedure with no reported adverse effect on the patient.
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