Catalog Number AI-07136 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that "the balloon did not inflate during use on a patient.Therefore, the catheter was removed and replaced with another kit, inserted at the same site.The replaced one inflated normally and the procedure was completed without problem." no patient harm or injury.The patient status is reported as "fine".
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Manufacturer Narrative
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Qn#(b)(4).
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Manufacturer Narrative
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(b)(4).The reported complaint that the "balloon did not inflate during use on a patient" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "the balloon did not inflate during use on a patient.Therefore, the catheter was removed and replaced with another kit, inserted at the same site.The replaced one inflated normally and the procedure was completed without problem." no patient harm or injury.The patient status is reported as "fine".
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Search Alerts/Recalls
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