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 12/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported that during a polarsheath was selected for use on a cryoablation procedure.While advancing the catheter into the sheath, aspiration from the sheath side port was performed to avoid air contamination.In this case, more air bubbles than usual were observed in the aspirated blood.The procedure was completed using the same polarsheath.At the conclusion of the procedure, coronary angiogram (cag) was performed and confirmed that there was no thrombus formation.
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Manufacturer Narrative
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Type of reportable event h1: corrected from serious injury to malfunction.The device was received at boston scientific for analysis.Visual inspection noted blood on the handle and the in flush-line of the sheath.Functional tests were performed, and there were no signs of bubbles in the flushing line during the test/syringe vacuum.Hemostatic valve testing was performed, and the device passed the test method as currently released without a dilator inserted during the test.No leakage, dripping and/or pressure drop was observed through the hemostatic valve, nor the flush-line side port.The device was gently pressurized with 6 psi at the flushing line lure fitting while plugging the distal tip of the catheter, using an isacc tester.The valve body was then submerged in a beaker of water, and no bubbles appeared.The pressure decay value passed as 0.0087.The device was under a pumping process for 5 minutes, and no issues appeared on the metriq pumping system.The reported event was not confirmed.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
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Event Description
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It was reported that a polarsheath was selected for use during a cryoablation procedure.While advancing the catheter into the sheath, aspiration from the sheath side port was performed to avoid air contamination.In this case, more air bubbles than usual were observed in the aspirated blood.The procedure was completed using the same polarsheath.At the conclusion of the procedure, a coronary angiogram (cag) was performed and confirmed that there was no thrombus formation.
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Search Alerts/Recalls
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