The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rear0003 showed no other similar product complaint(s) from this lot number.
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The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that the implicated product caused or contributed to the reported patient death was inconclusive due to the nature of the complaint and the evidence provided for investigation.Based on the information received, the patient's conscious level dropped after placement of the catheter and during implantation of the port for chemotherapy of stomach cancer.The left axillary vein was accessed with ultrasound guidance.It was reported that a resuscitative maneuver, including atropine administration, was performed.The patient died on the same day as the port and catheter insertion procedure.Air in the vessel was allegedly confirmed by postmortem ct.One 6.5fr airguard introducer sheath, which had been peeled, was returned for investigation.No damage was observed on the sheath, tabs, or airguard valve.The ptfe sheath exhibited a uniform peel.It was reported that the insertion procedure included off-label techniques with non-bard components.Potential contributing factors include insertion technique and/or procedural complications with catheter placement and patient risk factors.It was reported that the introduction of a guidewire was reportedly troublesome and took time due to tortuosity in the brachiocephalic vein.The air embolism may have occurred due to the complications encountered during the procedure; however, the exact cause of the reported event could not be determined.The product ifu provides the established sequence of events for insertion, which do not involve non-bard components.One of the precautions in the ifu states, ¿fill (prime) the device with sterile heparinized saline or normal saline solution to help avoid air embolism.¿ one of the warnings in the product ifu states, "during placement through a peel-away introducer sheath, hold thumb over exposed opening of sheath to prevent air embolism.The risk of air embolism is reduced by performing this part of the procedure with the patient performing the valsalva maneuver." the ifu also states, ¿the use of a subcutaneous port provides an important means of venous access for critically ill patients.However, the potential exists for serious complications, including the following: air embolism¿.For a cut-down procedure, the ifu states, ¿perform vessel incision after vessel is isolated and stabilized to prevent bleeding and air embolism.¿ a review of the device history record (dhr) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rear0003 showed no other similar product complaint(s) from this lot number.
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