Model Number 24628 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/26/2022 |
Event Type
malfunction
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Event Description
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It was reported that the blade was detached.A 5.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade got dislodged from the patient after removal from the sheath.The procedure was completed with another of the same device.There was no problem with the patient's condition.
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Event Description
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It was reported that the blade was detached.A 5.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade got dislodged from the patient after removal from the sheath.The procedure was completed with the same device.There was no problem with the patient's condition.It was further reported that the blade seemed to come off when it came out of the sheath.When the physician felt it was caught inside the sheath, he took it out.The device was used without any problems.
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Manufacturer Narrative
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Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.An examination of the balloon material and marker bands identified no issues which could potentially have contributed to this complaint.A visual examination observed damage to one of the blades of this device.One blade was returned fully detached from its pad.The blade was returned within gauze and surgical strip and could not be removed.A microscopic examination of the blades pad found that the pad was fully adhered to the balloon surface.No damage was noted on any of the other 3 blades and no tip damage was noted.A visual and tactile examination of the shaft/hypotube identified no issues.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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