BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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Model Number 3851 |
Device Problems
Break (1069); Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/09/2020 |
Event Type
Injury
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Event Description
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It was reported that the balloon was difficult to remove.The target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon was introduced and during the procedure, the balloon was inflated once up to 12atm.After inflation, an attempt was made to remove the device but the balloon might not have been completely deflated and it became stuck.Eventually, the shaft was cut and the device was covered with a guide extension catheter which enabled the devices to be removed together.Once the balloon was outside the patient, it was noted that a blade fragment was missing.Intravascular ultrasound was used to check for the blade, but it was not found inside the patient.This completed the procedure.There was no patient injury.
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Event Description
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It was reported that the balloon was difficult to remove.The target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon was introduced and during the procedure, the balloon was inflated once up to 12atm.After inflation, an attempt was made to remove the device but the balloon might not have been completely deflated and it became stuck.Eventually, the shaft was cut and the device was covered with a guide extension catheter which enabled the devices to be removed together.Once the balloon was outside the patient, it was noted that a blade fragment was missing.Intravascular ultrasound was used to check for the blade, but it was not found inside the patient.This completed the procedure.There was no patient injury.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A blade segment from one of the blades was found to be missing from its pad and 1mm of the pad segment which had contained the missing blade segment, was raised distally from the balloon material.The remainder of the pad and the blade were found to be securely bonded to the balloon material.All other blades were found to be securely bonded to the balloon material.The device was returned with its hub removed.The hub was not returned with the device.Multiple kinks were noted along the length of the device.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.No other issues were identified during the product analysis.
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