Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified.No actions will be taken at this time.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.In this case, the patient required a new stick to insert a new catheter.It is unknown if user or procedural factors may have contributed to this event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.(b)(4).
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It was reported that during the placement of a swan ganz catheter, there was resistance at the level of the thermal filament and a complete blockage of the proximal level when passing the catheter through the distal end of the introducer.The catheter was removed and a new placement was needed.There was no allegation of patient injury.Patient demographics could not be obtained, as the customer was unable to provide any further information about this event including the model number of the introducer or the product was available for return.
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Our product evaluation laboratory received one tuohy-borst type introducer.Blood was visible in the valve housing and the sheath body.The returned catheter had resistance while passing through the returned introducer sheath.The introducer sheath¿s outer diameter was measured to be 0.1398" and inner diameter was measured to be 0.102".No visible damage was found on the introducer.The customer report of a catheter insertion issue was confirmed on evaluation with the returned catheter; however, the issue was not able to be evaluated because the model of the returned introducer was unknown.The introducer appeared to match the specification of an 8f introducer, which is not the recommended 8.5f introducer size sited in the ifu for the returned catheter (model 774f75).
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