Catalog Number AI-07134 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/11/2023 |
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 and completed the procedure.No harm to the patient was reported".The patient status is reported as "fine".
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Manufacturer Narrative
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(b)(4).Other remarks: n/a.Corrected data: n/a.
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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" was not able to be confirmed as 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 was undetermined.No further action required at this time.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 and completed the procedure.No harm to the patient was reported".The patient status is reported as "fine".
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Search Alerts/Recalls
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