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Device code 2017 - incorrect prep.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It was reported that the balloon was not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.The reported patient effects of hypotension, occlusion and death are listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use as known patient effects.The investigation was unable to determine a conclusive cause for the reported leak and inflation issue.The reported unexpected medical intervention appears to be related to circumstances of the procedure.A conclusive cause for the reported patient effects of bradycardia, cardiac arrest, hypotension, obstruction/occlusion and death and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.A review of the echo report as well as a review of the cine images from the procedure was performed by an abbott vascular medical affairs representative.During the live medical review, the physician ascertained that there was a hole in the catheter, roughly ¿5-6cm proximal to the balloon or near the wire exit port¿, where the contrast/saline solution was exiting the balloon.There was no leak or damage noted to the device during the inspection prior to use or during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is possible that the bdc interacted with the patient anatomy and/or accessory device during advancement resulting in the noted hole, the reported leak and subsequently the reported inflation issue; however, since the device was not returned to abbott vascular to further evaluate, a conclusive cause could not be determined.Additionally, it was reported that the patient experienced hypotension, bradycardia, respiratory distress, no flow, and additional treatment with cpr was performed; however, the patient expired.H6: medical device problem 1546 removed.Health effect clinical code 1697 removed.
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It was reported that the procedure was to treat an unspecified artery.The 2.5x15mm trek rx balloon dilatation catheter (bdc) balloon ruptured and air got in the patient.The patient went into cardiac arrest and expired.Subsequent to the initially filed report, the following information was provided: the procedure was to treat a 90% stenosed, mild to moderate calcified vessel in the mid left anterior descending (lad) artery.The bdc was not soaked prior to use but was flushed and prepared with negative pressure outside the body.The device was prepared (air aspiration) outside the anatomy prior to use without any issues.The preparation included all air being removed from the balloon device with negative pressure then 50/50 contrast and saline solution used to prep the balloon and indeflator so only solution was in the indeflator.There was no resistance during advancement.The balloon was intended to be inflated with a pressure of 6 atmospheres (atms), however, under fluoroscopy there was no evidence the balloon inflated.There was no air but only contrast was seen proximal to the balloon upon inflation.It was noted that there was a leakage of material approximately 4-7cm from the shaft near the guide wire exit port.After 30 seconds the patient had hypotension, bradycardia, and respiratory distress, no flow and cpr was performed.The physician stated the trek bdc contributed to the patient death.No additional information was provided.
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