Model Number 0684-00-0296-01 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/01/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
|
|
Event Description
|
The following was reported via medwatch mw5103751 received 28-sep-2021: patient waiting oht, required placement of iabp for worsening cardiogenic shock.Right axillary iabp placed (b)(6) 2021.Removed and replaced in left axillary (b)(6) 2021 due to iabp rupture on (b)(6) 2021.Left axillary iabp removed and replaced w/right femoral iabp due to rupture on (b)(6) 2021, patient underwent oht.Subsequently discharged for rehab.Fda safety report id # (b)(4).This report is for the second iab used.A separate report will be submitted for the first iab.
|
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-19 through aug-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint (b)(4).
|
|
Search Alerts/Recalls
|