The consultant interventional radiologist a left common iliac angioplasty +/- stenting procedure on the male patient, who had pre-existing condition of left common iliac disease.It was noted that there was very tight stenosis located in the left common iliac artery.The consultant interventional radiologist crossed with a wire guide and another manufacturer's 8mm x 6cm balloon was inflated.The result was sub optimal so it was decided to use cooks' 9mm x 6cm advance 35 balloon and inflated to 5-6 atmospheres.At this point, it was noted that the balloon had burst, so the wire guide was inserted further as a precaution, the consultant interventional radiologist attempted to pull back the balloon catheter.Resistance was felt and more tension was applied on the balloon catheter.The consultant interventional radiologist felt something give and the balloon catheter was removed from the introducer sheath.It was noted that the distal portion of the balloon catheter and tip were not attached.The wire was clipped to keep in place and the patient was taken to theatre (surgery) for a surgical cutdown to remove the foreign object with surgical forceps.A section of the device remained within the patient's body (distal portion of the balloon catheter and tip of balloon catheter).A surgical cutdown was conducted to remove the foreign object.The patient did not experience any adverse effects due to this occurrence and the patient is ok, but did complain of pain in his left leg as well as having to have an additional surgical procedure.
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Event evaluation: a review of complaint history, instructions for use (ifu), quality control, trends, and a visual inspection of the returned device were conducted during the investigation.One used and damaged device was returned in two pieces along with an unmarked guidewire.The proximal piece contained the hub, catheter shaft up (separated just past the proximal balloon bond), one marker band, and 3.2 cm of balloon distal to the marker band.The marker band was not firmly attached indicated that it had shifted off of stretched catheter material.The proximal piece of the balloon displayed evidence of a linear rupture, and likely tore circumferentially during difficult removal.There was a small dent in the catheter shaft, about 5.7 cm proximal to the proximal balloon bond, otherwise the shaft was appeared undamaged except at the point of separation.The distal piece contained catheter shaft material, one marker band, the distal tip, and the distal portion of the balloon.The distal piece was stuck on a wire guide which measured 0.035" in diameter.The shaft material appeared severely stretched and kinked.The wire guide was also kinked in multiple locations.The distal piece measured approximately 11.5 cm in length, but could not be fully straightened out when measuring.The marker band was firmly attached, but was not under the balloon material.Instead the marker band was approximately 1 cm from the proximal end.Due to the firm attachment and placement, it is believed that this is the proximal marker band, and the distal marker band was the marker band located on the proximal piece (which was not firmly attached).The distal marker band likely slid out of place as the tubing is stretched towards the distal end, causing it to slide towards the proximal end during attempted removal.The distal balloon measured about 3.3 cm in length, but was severely scrunched and thus was difficult to measure.As the balloon should be 6 cm in length between the marker band, it appears as though the entire balloon is present between the two pieces.The distal end of the balloon on the distal piece was completely connected around the entire circumference.There was however a hole/tear about 1 mm in from the distal end.This hole/tear measured about 8 mm in length and 5 mm in width, but the piece of the balloon was still attached (the piece that would fill the hole, making the balloon complete).The distal tip appeared undamaged.Each device is shipped with instructions for use, which states the appropriate uses, contraindications, warnings and precautions, and proper usage procedures including proper inflation and deflation procedures.The ifu states: do not exceed rated burst pressure and do not use a power injector for balloon inflation or injection of contrast medium as rupture may occur.The ifu also states, if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.The balloons are designed to burst linearly.The inspection revealed a linear burst.The burst may have begun linearly, and then could have tore circumferentially during difficult removal or if damaged by patient anatomy (such as a calcification) when a balloon tears circumferentially, it is typically difficult to withdrawal as the balloon may fold back on itself or scrunch up.The user reported that they brought the balloon to 5- atm which is below the rated burst pressure of 11 atm and below the nominal pressure of 8 atm, thus over inflation is not the cause of rupture.The user noted that they were inflating in an area of very tight stenosis.If there were any sharp calcifications present, they may have aided in the rupture and subsequent separation.The noted hole in the balloon after the burst area indicates that the balloon was damaged during the procedure (either from calcifications, during the removal process, or from another unknown cause) if the balloon and sheath/introducer were not removed as a unit after rupture, the introducer may have contributed to the separation as balloon rewrap would become difficult likely resulting in the balloon bunching up at the distal end of the introducer, leading to resistance, stretching and separation.It is possible that the patients anatomy could have contributed to the failure, but without additional images or information, a definitive root cause cannot be determined.The separated portion was retrieved from the patient.We have notified the appropriate internal personnel and will continue to monitor for similar complaints.
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