Model Number M004CRBS3050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pericardial Effusion (3271)
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Event Date 12/02/2021 |
Event Type
Injury
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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 a polarx, polarsheath and polarmap were used in a paroxysmal af (de novo) cryoablation procedure.The physician guided the polarsheath over a guidewire without resistance, trans-septal into the left atrium.While inserting the polarx balloon into the polarsheath and reaching the ostium of the lspv.After inflating the polarx balloon, no visible signs of cardiac decompensation were noted.Only after administration of contrast agent for occlusion assessment did the blood pressure drop significantly and under fluoroscopy the contrast medium showed an unnatural flow behavior.The physician decided to stop the procedure immediately, and asked for a quick heart ultrasound investigation.A fulminant pericardial effusion was immediately recognizable, which prompted the physician for an emergency case and to puncture the effusion externally.After 1 1/2 liters of blood had been withdrawn, the patient's condition stabilized even under the administration of volume and drugs.The polarx, polarsheath and polarmap devices were removed without performing ablation.The devices are expected to be returned to boston scientific for analysis.
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Manufacturer Narrative
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Visual inspection of the device showed kinks in main shaft.Blood was observed in the flush-line.Salt particles on steering knob and a clenched distal end of main shaft were also noted.There was a small uncontrolled tear on the surface of the outer slit yet leaks were not 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 5.5 psi in hemostasis testing.Steering also held deflection without holding steering knob.There is no evidence this device was used in a manner inconsistent with the labeled 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 polarx, polarsheath and polarmap were used in a paroxysmal af (de novo) cryoablation procedure.The physician guided the polarsheath over a guidewire without resistance, trans-septal into the left atrium.While inserting the polarx balloon into the polarsheath and reaching the ostium of the lspv.After inflating the polarx balloon, no visible signs of cardiac decompensation were noted.Only after administration of contrast agent for occlusion assessment did the blood pressure drop significantly and under fluoroscopy the contrast medium showed an unnatural flow behavior.The physician decided to stop the procedure immediately, and asked for a quick heart ultrasound investigation.A fulminant pericardial effusion was immediately recognizable, which prompted the physician for an emergency case and to puncture the effusion externally.After 1 1/2 liters of blood had been withdrawn, the patient's condition stabilized even under the administration of volume and drugs.The polarx, polarsheath and polarmap devices were removed without performing ablation.The devices have been returned to boston scientific for analysis.
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Search Alerts/Recalls
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