Model Number 1012451-12 |
Device Problems
Difficult to Remove (1528); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2022 |
Event Type
malfunction
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Event Description
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T was reported that the procedure was to treat a 90% stenosed, mildly calcified vessel without tortuosity in the mid right coronary artery (mrca).After a 3.5mm drug eluting stent was deployed in the mrca, there was malapposition at the proximal edge.The 3.5x12mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation.However, the balloon ruptured during the first inflation at 12atm for 10 seconds.Prior to use, the catheter was soaked in saline and was prepared (air aspiration) inside the anatomy.There was no resistance when the protective sheath was removed and there was no resistance during advancement.There was resistance with a guide catheter during removal.A non-abbott balloon was used to complete the procedure.There was no adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a 90% stenosed, mildly calcified vessel without tortuosity in the mid right coronary artery (mrca).After a 3.5mm drug eluting stent was deployed in the mrca, there was malapposition at the proximal edge.The 3.5x12mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation.However, the balloon ruptured during the first inflation at 12atm for 10 seconds.Prior to use, the catheter was soaked in saline and was prepared (air aspiration) inside the anatomy.There was no resistance when the protective sheath was removed and there was no resistance during advancement.There was resistance with a guide catheter during removal.A non-abbott balloon was used to complete the procedure.There was no adverse patient effect.There was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: there was resistance with the guide catheter during removal but the nc trek bdc was removed independently.There was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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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.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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