Model Number 12TLW405F35 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned and an evaluation was completed.The reported issue was confirmed.The catheter balloon was unable to inflate with air.Occlusion was felt in the inflation lumen.Resistance was felt when inflating the balloon with distilled water.The balloon could not be deflated completely after 15 seconds by pulling back on the syringe plunger.The catheter body appeared reduced near proximal balloon windings.Cut down was performed on the catheter body to locate occlusion.Balloon inflation lumen was found to be collapsed near the proximal windings.The syringe plunger was received damaged.The balloon latex, bushings and windings were intact.The thru lumen was patent without any leakage or occlusion.No visible damage was observed from catheter body.An engineering task has been assigned for further investigation.The device history record review was completed and all manufacturing inspections passed with no non conformances.
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Event Description
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It was reported that there was a failure with the fogarty thru lumen embolectomy catheter, during use.The balloon stopped inflating and deflating.There was no medical intervention.The balloon was removed successfully, however, there was difficulty with deflation.Attempts were made for additional information, but there is no additional information available.There was no patient harm or injury.
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Manufacturer Narrative
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The engineering evaluation was completed.The root cause was determined to be manufacturing, associated with the collapse of the balloon inflation lumen.The instructions for use ifu instructs the user that the catheter should be inspected with the balloon inflated during purging.In addition, as part the manufacturing process, 100 percent of the units are inspected.A product risk assessment was completed and no unreasonable risks were identified.A capa was opened to assess for any corrective actions required for this issue.Corrective actions were implemented to address manufacturing non-conformance.
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Search Alerts/Recalls
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