Model Number IPN923527 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2022 |
Event Type
malfunction
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Event Description
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It was reported that "the balloon did not inflate enough during use.Therefore, it was removed and replaced with another kit of the same product, inserted at the same site to complete the procedure without problem.The user flushed the first sample but did not perform the inflation test before use".The patient health condition is reported as "fine".
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Manufacturer Narrative
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Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
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Manufacturer Narrative
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Qn#(b)(4).The reported complaint that the "balloon did not inflate enough during use" 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.The reported complaint will be monitored for any developing trends.Additionally, according to the event details, the user "did not perform the inflation test before use".As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.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 enough during use.Therefore, it was removed and replaced with another kit of the same product, inserted at the same site to complete the procedure without problem.The user flushed the first sample but did not perform the inflation test before use".The patient health condition is reported as "fine".
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Search Alerts/Recalls
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