Model Number M004CRBS3050 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
malfunction
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Event Description
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It was reported that a polarsheath was used in a atrial fibrillation cryoablation procedure.After inserting the catheter into the patient the physician tried to asperate through the side port, but the air was pulled out.The sheath was exchanged and the procedure was completed with no patient injury.
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Event Description
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It was reported that a polarsheath was used in a atrial fibrillation cryoablation procedure.After inserting the catheter into the patient the physician tried to aspirate through the side port, but the air was pulled out.The sheath was exchanged and the procedure was completed with no patient injury.
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Manufacturer Narrative
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Visual inspection of the device showed blood within sheath and flush line.A kink was also noted in the flush line.There was no sign of an uncontrolled tear on the surface of the outer slit there and no leaks were observed.The sheath passed all standard manufacturing testing without any leak values in the pressure decay test; no visible bubbles in the flush line during aspiration through various speeds; and no dripping liquid leaks from the proximal end while pressurized at in hemostasis testing.There is no evidence this device was used in a manner inconsistent with the labeled indications.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
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Search Alerts/Recalls
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