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 03/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned for evaluation.The reported deflation issue was confirmed.The balloon inflated with 1.7ml of air and it inflated concentric and did not leak.Resistance was felt when inflating with distilled water.The balloon could not be deflated completed after 15 seconds by pulling back on the syringe plunger.Cut down was performed on the catheter body to locate occlusion.Balloon inflation lumen was found to be collapsed near the proximal windings.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 has been 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 malfunction with a fogarty thru lumen embolectomy catheter, during use.Per the customer, the technician that was in the case did not prep the device before starting the case.The issue could have been found before use.The doctor was able to inflate the catheter balloon, but could not deflate enough to pull it out of the sheath.The sheath and the catheter were removed and a new sheath was inserted with a new catheter.There was no patient injury or harm.
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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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