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Catalog Number DYND11574 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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According to the customer, on (b)(6) 2023 the catheter that was placed on (b)(6) 2023 came out with the "balloon deflated".The customer reported the catheter was a "20fr 30ml balloon catheter".The customer reported the catheter was replaced.The customer did not report any serious injury, medical intervention/attention, or follow up care related to the reported incident.Sample requested for return evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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Event Description
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According to the customer, on (b)(6) 2023 the catheter that was placed on 10/01/23 came out with the "balloon deflated".
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Search Alerts/Recalls
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