Catalog Number 1012268-12 |
Device Problems
Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned for analysis.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the 75% stenosed and heavily calcified artery during advancement causing the reported difficult to advance.It is likely the balloon was damaged due to the interaction with the difficult anatomy during advancement and/or due to interaction with the difficult anatomy during inflation causing the reported material rupture.Continued interaction with the difficult anatomy during removal likely caused the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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It was reported that the procedure was to treat the right coronary artery (rca) with 75% stenosis and heavy calcification.The vessel diameter was 2.5 mm and the length was 30 mm.The 1.2x12 mm mini trek balloon dilatation catheter (bdc) was advanced and possibly became caught on calcification with the lesion.The bdc ruptured during the first inflation at an unknown pressure.There was resistance noted with the lesion during removal; however, the balloon was fully deflated.A non-abbott bdc was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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