The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.
|
One catheter with attached monoject 1.5 cc limited volume syringe and two three-way stopcocks was returned for evaluation.A non-edwards introducer with non-edwards contamination shield was located on the catheter body between 32 cm and 90 cm proximal from the catheter tip.No packaging was returned.As received, blood was observed from the strain relief of the optical module connector.The attached non-edwards introducer and non-edwards contamination shield were removed for further evaluation.The catheter body was found to have two punctures, 0.5mm long and <0.5mm long respectively, at 103 cm proximal from the catheter tip.Scratch marks were observed around the punctures.The punctures entered into the distal lumen and optical fiber lumen.The proximal injectate lumen was patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No visible damage to the balloon or returned syringe was observed.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of blood leakage issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.
|