Catalog Number 1014262-040 |
Device Problems
Deflation Problem (1149); Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to perform percutaneous transluminal angioplasty (pta) on an in situ bypass with fibrotic tissue of the femoral artery.The 4.0x40mm armada 18 balloon catheter was prepared (air aspiration) outside the anatomy prior to use.There was no difficulty removing the stylet or protective sheath, however, there was resistance to inflate the balloon.The balloon was taken out of the anatomy partially inflated as a single unit without resistance.The physician tried to inflate it with contrast on the table but did not succeed.He got some small amount of contrast and then air into the balloon.He then tried to remove the contrast and air out of the balloon and it was not possible.The physician concluded something was blocking the contrast lumen and took another armada 18 that was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Visual, dimensional and functional inspections were performed on the returned device.The reported inflation and deflation issues could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaints.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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