Catalog Number 1013065-12 |
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 07/20/2021 |
Event Type
malfunction
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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 of the reported lot did not indicate a lot specific quality issue.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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Event Description
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It was reported that the procedure was performed to treat a 99% stenosed, moderately tortuous, and heavily calcified lesion in the distal right coronary artery.A 2.00x12mm traveler rx balloon dilatation catheter (bdc) was prepared per the instructions for use.The bdc was advanced but resistance with the anatomy was felt.Once at the target lesion, the balloon ruptured during the first inflation at 8 atmospheres.The bdc was removed but resistance with the anatomy was felt.The procedure was successfully completed with an unspecified cutting balloon and the deployment of an unspecified drug eluting stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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