Model Number A2025-120 |
Device Problems
Product Quality Problem (1506); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2021 |
Event Type
malfunction
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Event Description
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It was reported that prior to inserting the 2.50x120mm armada 14 balloon dilatation catheter (bdc) into the sheath, it was noted the balloon looked irregular, like it had a bubble.The bdc was not used.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.Return device analysis noted the balloon was ruptured.
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Manufacturer Narrative
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The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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A visual inspection was performed on the returned device and the reported irregular texture/wrinkled balloon was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the reported information and review of similar incident(s) there is no indication of a lot specific product quality issue.The investigation was unable to determine a conclusive cause for the reported irregular appearance and the noted balloon rupture.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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