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Catalog Number SBI070040080 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 09/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician was treating a little calcified lesion in the right sfa using admiral xtreme balloon catheter.The device was intended to pre-dilate the vessel.It was reported that the balloon burst at 20atm during balloon inflation.After burst of the balloon, it was difficult to retrieve the balloon through the sheath.Force was required to get it back out of the sheath, then the marker was noticed on the wire and could not be retrieved into the sheath.A snare was needed to remove wire with marker.Balloon came back out of the sheath in several parts.All fragments of the balloon were retrieved from the patient.Excessive force was used during withdrawal.Extra sheath was placed in the contra lateral groin.The vessel was non-tortuous, with 80% lesion stenosis, vessel diameter 7mm and lesion length 20mm.There was resistance encountered when advancing the device and device did not pass through a previously deployed stent.There was no damage on packaging and no issues noted when removing device from hoop.The device was prepped per ifu with no issues identified.There were no clinical sequelae reported.
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Manufacturer Narrative
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Device evaluation summary: the device returned for evaluation.The information provided on the luer and label are consistent with the complaint form report.The device was full of hardened blood and broken in pieces.A visual and a tactile inspection was carried out on the device with the following results: the balloon broke at approximately 2 cm from the proximal balloon welding; the distal part of the balloon was missing together with distal marker; the guidewire lumen underneath the balloon was stretched.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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