Model Number B2080-040 |
Device Problems
Entrapment of Device (1212); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2022 |
Event Type
Injury
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Event Description
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It was reported that the procedure was to treat a heavily calcified, mildly tortuous, de novo lesion in the right common femoral artery.After an unspecified stent was implanted in the right common femoral artery, post-dilatation was being performed with an 8x40mm armada 35 balloon dilatation catheter (bdc), when the balloon ruptured due to the heavy calcification at the lesion.The bdc was then being removed from the anatomy when it became stuck with the tip of the sheath.It was decided that the bdc and sheath would be removed from the lesion as a single unit, however the balloon became stuck in calcium, while the sheath was removed intact.The bdc became separated, and the tip of the device was left inside the vessel.The patient was put under general anesthesia (ga), and a cut down procedure was performed to successfully remove the ruptured balloon from the anatomy.There was no adverse patient sequela, however there was a reported clinically significant delay due to the cut down procedure.No additional information was provided.
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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Visual inspection was performed on the returned device.The reported balloon rupture and separation were confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.The reported entrapment of device could not be replicated in a testing environment as it was based on operational circumstances.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.The investigation determined the reported balloon rupture, difficulty removing the device, balloon separation, entrapment of device, delay to treatment/therapy, surgical intervention, removal of foreign body and hospitalization appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Search Alerts/Recalls
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