Model Number IPN000084 |
Device Problem
Inflation Problem (1310)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/20/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
|
|
Event Description
|
The report states that "the balloon did not inflate properly during use.Therefore, the catheter was replaced with another kit of the same lot to complete the procedure.The user flushed the catheter but did not perform the inflation test before use." additional information states that the secondary catheter was inserted at the same insertion site.No report of patient harm or injury.
|
|
Event Description
|
The report states that "the balloon did not inflate properly during use.Therefore, the catheter was replaced with another kit of the same lot to complete the procedure.The user flushed the catheter but did not perform the inflation test before use." additional information states that the secondary catheter was inserted at the same insertion site.No report of patient harm or injury.
|
|
Manufacturer Narrative
|
Qn# (b)(4).The reported complaint that the "balloon did not inflate properly 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.
|
|
Search Alerts/Recalls
|