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During a diagnostic cerebral angiography, a thrombus developed as soon as the guidewire was withdrawn from the 5f ver 135 degree 100cm tempo catheter.The catheter was clogged in a few seconds.The customer changed the catheter with a non cordis one and the procedure was finished with success.The patient was not injured.The device will be returned for analysis.A decision from physician to withdraw all catheters with the same lot numbers from the shelf was made.No other information was reported.A non-sterile cath tempo 5f ver 135 degree 100 cm diagnostic catheter, along with five sterile units of the same diagnostic cath tempo 5f ver 135 degree 100 cm were received for analysis inside two separated plastic bags.The sterile pouches were received ply folded, labeled as catalog 451514h0, lot number 17797905.Per visual analysis, the body shaft of the five sterile units were inspected and no anomalies could be noted.However, the body shaft of the non-sterile unit was noted to be kinked.A severe kink was located on the body shaft of the unit at 31.3 cm from the distal tip.No other anomalies were noted.Neither microscopic analysis to inspect the unit under x-ray nor other analysis to verify any material causing an obstruction were performed to the received unit since the device did not present with any material obstruction.Per functional analysis, a lab sample syringe filled with water was attached to the hubs of the catheters and successfully flushed.Neither resistance nor loose material/ matter was noted during the flushing procedure either on the non-sterile unit or on the sterile units.Then, a lab sample.038¿ emerald guide wire was inserted into the units.The insertion/withdrawl test was successfully performed on the sterile units.However, the wire was not able to be inserted into the non-sterile catheter via tip as well as via hub lumen.The guide wire lab sample was advanced into the non-sterile unit only up to the kinked condition where strong resistance was felt/experienced when trying to advance the guide wire through the previously mentioned kinked damage.Per dimensional analysis, the non-sterile catheter outer diameter (od) and inner diameter (id) were measured near the kinked area on the catheter body shaft area and results were found within specification.A product history record (phr) review of lot 17797905 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿catheter (body/shaft) obstructed - in-patient¿ and ¿thrombus in catheter¿ were not confirmed since no material causing an obstruction was present.However, the unit presented with a severe kinked condition as received.Nonetheless, the exact cause of the kinked condition found on the catheter could not be conclusively determined during the analysis.Procedural and handling factors may have contributed to the reported event.Per the instructions for use (ifu), which is not intended as a mitigation, ¿before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.Complications: procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.Possible complications include but are not limited to the following: air embolism, hematoma at the puncture site, infection, perforation of the vessel wall.¿ the phr review and the product analyses results do not suggest that the reported event could be related to the manufacturing process.Therefore, no actions will be taken.
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