We received one 774f75 catheter with attached monoject 1.5cc limited volume syringe and cal-cup.The customer report of balloon issue was confirmed.The balloon was found to have a tear in the proximal end of the distal bond extending completely around the circumference of the balloon.A section of latex at the site of damage was missing and was not returned.The edges of latex were uneven and rough.All through lumens were patent without any leakage or occlusion.A device history record review was completed and documented that the device met all specifications upon distribution.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this 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.It is common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter.When there is separation of the balloon or fragments from the pulmonary artery catheter, the retained fragment will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated.Pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture, the balloon should not be inflated above the recommended volume.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.Udi number is (b)(4).
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It was reported that, before use, the balloon burst.No report of patient involvement.Inquired of patient demographics, but facility stated demographics are no longer available.
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