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Model Number 3280 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Respiratory Distress (2045); Injury (2348)
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Event Date 11/16/2020 |
Event Type
Death
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Manufacturer Narrative
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Patient weight: (b)(6) kg.
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Event Description
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It was reported that the patient had a very severe reaction and the procedure was cancelled.The target areas were in 70% stenosed ostial, 80-90% stenosed proximal to middle, and 80% stenosed distal end of the left circumflex artery.A rotalink advancer and a 1.25mm rotalink burr were selected for use.During procedure, the patient had a very severe reaction and rescue was carried out.It was found after the procedure that the middle part of the rotablator catheter was leaking liquid.The procedure was cancelled.
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Manufacturer Narrative
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A4: weight: 75.9 kg.B2: date of death was approximated.
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Event Description
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It was reported that the device was leaking liquid, the patient had a very severe reaction and the procedure was cancelled.The target areas were in 70% stenosed ostial, 80-90% stenosed proximal to middle, and 80% stenosed distal end of the left circumflex artery.A rotalink advancer and a 1.25mm rotalink burr were selected for use.During procedure, the patient had a very severe reaction and rescue was carried out.It was found after the procedure that the middle part of the rotablator catheter was leaking liquid.The procedure was cancelled.No further patient complications were reported.It was further reported that when the device was removed, it was found that the sheath of the 1.25mm rotalink burr was leaking.There was no device issue with the rotalink advancer.The patient was treated with a defibrillator and cannula.The patient was transferred to the cardiac care unit, and after a few days the patient died due to pulmonary atelectasis.It was further reported that the device passed pre-procedure testing and a catheter fracture may have occurred during the procedure.During pull back, the liquid was not flowing from the head of the burr and there was no cooling and lubrication effect.This may have caused the patient to have a severe reaction during the rotablation procedure.The leaking site was located in the very proximal of the burr catheter and it seems this part was always within the guiding catheter lumen and would not touch the patient's vessel during the procedure, so the fracture may not have been caused by the patient lesion.
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Manufacturer Narrative
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Weight: (b)(6).Date of death was approximated.
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Event Description
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It was reported that the patient had a very severe reaction and the procedure was cancelled.The target areas were in 70% stenosed ostial, 80-90% stenosed proximal to middle, and 80% stenosed distal end of the left circumflex artery.A rotalink advancer and a 1.25mm rotalink burr were selected for use.During procedure, the patient had a very severe reaction and rescue was carried out.It was found after the procedure that the middle part of the rotablator catheter was leaking liquid.The procedure was cancelled.It was further reported that when the device was removed, it was found that the sheath of the 1.25mm rotalink burr was leaking.There was no device issue with the rotalink advancer.The patient was treated with a defibrillator and cannula.The patient was transferred to the cardiac care unit, and after a few days the patient died due to pulmonary atelectasis.
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Event Description
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It was reported that the device was leaking liquid, the patient had a very severe reaction and the procedure was cancelled.The target areas were in 70% stenosed ostial, 80-90% stenosed proximal to middle, and 80% stenosed distal end of the left circumflex artery.A rotalink advancer and a 1.25mm rotalink burr were selected for use.During procedure, the patient had a very severe reaction and rescue was carried out.It was found after the procedure that the middle part of the rotablator catheter was leaking liquid.The procedure was cancelled.No further patient complications were reported.It was further reported that when the device was removed, it was found that the sheath of the 1.25mm rotalink burr was leaking.There was no device issue with the rotalink advancer.The patient was treated with a defibrillator and cannula.The patient was transferred to the cardiac care unit, and after a few days the patient died due to pulmonary atelectasis.It was further reported that the device passed pre-procedure testing and a catheter fracture may have occurred during the procedure.During pull back, the liquid was not flowing from the head of the burr and there was no cooling and lubrication effect.This may have caused the patient to have a severe reaction during the rotablation procedure.The leaking site was located in the very proximal of the burr catheter and it seems this part was always within the guiding catheter lumen and would not touch the patient's vessel during the procedure, so the fracture may not have been caused by the patient lesion.
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Manufacturer Narrative
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A4 - weight: 75.9 kg.B2: date of death was approximated.Device evaluated by mfr: the device was returned for evaluation.The advancer and handshake connection were microscopically and visually examined.The handshake connection is kinked and partially broken at the kinked location.There were no abnormal noises or leaks and the device did not run; so it was not able to get any speed.The advancer was dismantled, and the turbine was found to be corroded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the drive shaft does not rotate.
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Search Alerts/Recalls
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