Brand name) vital-port detached silicone catheter with introducer set and obturator titanium infusion port.Common device name) dwf catheter, cannula and tubing, vascular, cardiopulmonary bypass.Pma#) k931586.Investigation - evaluation a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: warnings: "introduction of the catheter into the subclavian vein using standard percutaneous techniques may subject the catheter to periodic compression forces within the narrow costoclavicular space between the clavicle and the first rib.Reported complications from repeated subclavian compression include catheter pinch off syndrome, catheter fracture, and catheter shear followed by embolization of the distal portion." based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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