(b)(4).The serial number ( (b)(6) ) recorded on the complaint report matches the serial number on the returned sample.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number on the returned sample.Upon return, the device was returned in two separate sections.The total length of the first section (section 1) is approximately 76.5cm long and included the iabc bifurcate assembly, central lumen, outer lumen, and some portion of the iabc bladder membrane.The iabc central lumen (section 1) was noted broken/separated within the flex-tip assembly area at approximately 76.5cm from the iabc luer end; the damage to the central lumen within flex-tip assembly area appears consistent with being broken/separated.The iabc bladder was noted damaged at approximately 70cm from the iabc luer; the appearance at the area of the damaged iabc bladder membrane was consistent with being ripped/cut.Dried blood was noted within the iabc bladder membrane.The one-way valve was connected and tethered to the short driveline tubing.Numerous bends to the iabc central/outer lumen was noted at approximately 41cm, 46.5cm , 47.3cm, 50.5cm and 63cm from the iabc luer end.Dried blood was noted on the exterior surfaces of the returned iabc.The total length of the second section (section 2) is approximately 12.7cm long and included the iabc distal tip, flex-tip assembly (part of the iabc central lumen) and some portion of the iabc bladder membrane.The iabc central lumen (section 2) was noted broken/separated within the flex-tip assembly area at approximately 5.6cm from the iabc distal tip; the damage to the central lumen within flex-tip assembly area appears consistent with being broken/separated and the wire-round (part of the flex tip assembly) was also noted unraveled.The appearance at the area of the damaged iabc bladder membrane was consistent with being ripped/cut.Dried blood was noted within the iabc bladder membrane.Dried blood was noted on the exterior surfaces of the second section.The bladder thickness was measured at six points with measurements ranging from 0.0055in-0.0058in and was within specification.The one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.This was repeated five separate times with similar results.The one-way valve was properly cleaned and tested again; the one-way valve passed.A vacuum was pulled on the one-way valve, and it held for at least 1 minute and then 30 seconds five separate times.An attempt to aspirate and flush the iabc central lumen (section 1) using a 60cc lab-inventory syringe was unable to be successfully completed due to a blocked central lumen.Immediate push back on the syringe plunger was experienced.The blockage was most likely dried blood.Due to the returned state of the device, functional leak testing was unable to be performed.Upon further inspection, no obvious leak sites were noted.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip (section 2).The guidewire exited the central lumen and entered the bladder at the previously noted central lumen break.Some blood was noted on the guidewire.The guidewire was front loaded through the iabc luer end (section 1).Resistance was noted at approximately 41.2cm, 46.4cm , 50.1cm, 75.5cm from the iabc luer, which are the locations of the previously noted bends.Then the guidewire exited the central lumen at the previously noted central lumen break and dried blood had exited the central lumen with the guidewire.An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed before inserting the guidewire.Another attempt to aspirate and flush the catheter was successfully completed, after clearing blood from the central lumen during the guidewire test.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of iab blood in helium pathway is confirmed.During the investigation of the returned device, blood was confirmed within the helium pathway.Upon return, there were various damages to the iabc and the iabc was returned in two separate sections.There was a damaged/broken central lumen and damaged bladder.Due to the combined damages and returned state of the device, it could not be confidently determined what caused blood to enter the helium pathway or when the damages occurred.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the blood in the helium pathway.The root cause of how the blood entered the helium pathway is undetermined.No further action required at this time.This will be monitored for any developing trends.
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