No medical records or no medical images have been made available to the manufacturer.The lot number for the device has been provided.A review of the device history records is currently being performed.The investigation of the reported event is currently underway.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.
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It was reported that while post-dilating a stent, during the first inflation, the pta balloon allegedly ruptured at 18 atm in an upper arm a/v fistula.It was further reported that during retraction, the balloon catheter allegedly damaged and pulled the stent out of location.A previously implanted stent stopped the stent which allowed the balloon catheter to be retracted from the patient.Reportedly, another stent was used to treat the lesion and complete the procedure.
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A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: fiber strands were noted to be unraveled 3.1cm from the distal tip.The unraveled fibers measured approximately 9.0cm in length.No other anomalies were observed along the length of the device.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house guidewire, and it passed without issue.The inflation hub was connected to an inflation device, and an attempt was then made to inflate the balloon with water.Upon inflating, the balloon inflated asymmetrically due to the unraveled fibers and water was observed leaking through the fibers of the balloon, 4.1cm from the distal tip.The balloon was stripped of its fibers in order to locate the rupture.A pinhole rupture was found on the balloon, approximately 4.3cm from the distal tip.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned.The investigation for is confirmed for a pinhole rupture and unraveled fibers on the barrel of the balloon.The investigation is inconclusive for stent retraction issues, as functional testing could not be performed and the event could not be replicated.Labeling review: the current instructions for use (ifu)provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.
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