Model Number 24630 |
Device Problems
Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event- 18 years or older.(b)(6).
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Event Description
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It was reported that resistance was met upon removal and the blade was lifted.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.After dilatation was performed, resistance was met when the balloon was removed.Subsequently, the tip of the non-bsc introducer sheath got torn and one part of the blade became lifted.The procedure was completed with this device.No complications were reported and the patient's condition was good.
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Manufacturer Narrative
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Age at time of event: 18 years or older.Initial reporter (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device was received together with the non-bsc 6fr introducer sheath used during procedure.A visual and microscopic examination was performed on the returned device.It was noted that a proximal section of one of the blades measuring approximately 3mm was lifted distally from its blade pad.The blade pad remained undamaged and fully bonded to the balloon material.The damage is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device.All other blades were intact and fully bonded to the balloon material.Examination revealed the balloon had been inflated, however, the balloon material had a pinhole located approximately 4mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues.No issue was observed with the tip or markerbands of the device.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
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Event Description
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It was reported that resistance was met upon removal and the blade was lifted.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.After dilatation was performed, resistance was met when the balloon was removed.Subsequently, the tip of the non-bsc introducer sheath got torn and one part of the blade became lifted.The procedure was completed with this device.No complications were reported and the patient's condition was good.
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Event Description
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It was reported that resistance was met upon removal and the blade was lifted.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.After dilatation was performed, resistance was met when the balloon was removed.Subsequently, the tip of the non-bsc introducer sheath got torn and one part of the blade became lifted.The procedure was completed with this device.No complications were reported and the patient's condition was good.
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Manufacturer Narrative
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Age at time of event- 18 years or older.Initial reporter (b)(6).Correction to device evaluated by manufacturer: the customer's sheath was not returned for analysis.Device evaluated by manufacturer: the device was returned for analysis.The non-bsc sheath used during procedure was not returned.A visual and microscopic examination was performed on the returned device.It was noted that a proximal section of one of the blades measuring approximately 3mm was lifted distally from its blade pad.The blade pad remained undamaged and fully bonded to the balloon material.The damage is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device.All other blades were intact and fully bonded to the balloon material.Examination revealed the balloon had been inflated, however, the balloon material had a pinhole located approximately 4mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues.No issue was observed with the tip or markerbands of the device.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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