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Model Number 85364 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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On completion of the investigation a follow up report will be submitted.
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Event Description
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Report received stated that after the delivery of the stent in the chosen artery, during the withdrawal of the balloon, the latter remained blocked in the introducer, over 5 cm.As a result, the surgeon had to recover the wedged balloon via the femoral, contra-lateral approach.No clinical consequences for the patient were reported.
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Event Description
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N/a.
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Manufacturer Narrative
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Based on the details of the complaint, upon attempting to withdraw the device the balloon became stuck in the introducer sheath and became detached from the catheter shaft.The provided information shows that a 50/50 contrast ratio was used in the balloon.In regards to the amount of time allowed for the balloon to deflate the answer received was ¿30 seconds¿.The response also mentions that the balloon was not visualized to be fully deflated prior to attempting to remove the catheter.Based on these details, it is likely the balloon was not fully deflated prior to withdrawal.A review of applicable device history records was conducted.There were no nonconformances noted during any of the device builds and no indications of any manufacturing defect that could have contributed to the issue.Based on the details of the complaint and investigation conducted, it is likely that this complaint is of the same root cause as that identified in ongoing capa 429004, such that it is likely that the balloon was not allowed sufficient time to deflate prior to withdrawal of the balloon and/or was not visualized to be fully deflated under fluoroscopy.When there is fluid still remaining in the balloon, when the catheter is pulled back into the sheath the fluid gets pushed to the distal end of the balloon creating a plug at the end of the sheath.If too much force is applied the shaft will stretch and break near the proximal balloon weld and/or the manifold hub.It is for this reason that the most probable root cause is operational context.A secondary root cause is design, based on the findings of capa 429004, as with the use of contrast, the advanta v12 deflation time can take longer than the 40s as specified in the ifu (based on the use of water) for larger size balloons.Capa 429004 is currently in the implementation phase and this issue has been evaluated under hhe 2021005 and is associated with recall number z-1076-2022.H3 other text : device not returned.
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Search Alerts/Recalls
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