BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number 24630 |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 02/07/2020 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter city: (b)(6).
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Event Description
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It was reported that the blade was detached and dislodged inside the patient's body.The 75% stenosed target lesion was located in the upper arm shunt vessel.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure, after shunt dilatation was completed, the device was removed, but there was resistance felt.The balloon was returned into the vessel then it was rotated and then removed.However, during bailout procedure, it was noted that one blade on the balloon was missing.When it was extracted by echo near the sheath, it was confirmed that the blade was attached on the tip of the sheath.The physician revealed that the angle of the sheath tip was not good.The missing balloon blade might be left inside the patient's body.No additional intervention or treatment was performed.The procedure was completed with the same device.No patient complications reported and patient status was stable.
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Event Description
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It was reported that the blade was detached and dislodged inside the patient's body.The 75% stenosed target lesion was located in the upper arm shunt vessel.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure, after shunt dilatation was completed, the device was removed, but there was resistance felt.The balloon was returned into the vessel then it was rotated and then removed.However, during bailout procedure, it was noted that one blade on the balloon was missing.When it was extracted by echo near the sheath, it was confirmed that the blade was attached on the tip of the sheath.The physician revealed that the angle of the sheath tip was not good.The missing balloon blade might be left inside the patient's body.No additional intervention or treatment was performed.The procedure was completed with the same device.No patient complications reported and patient status was stable.
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Manufacturer Narrative
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E1 - initial reporter city: (b)(6).H6 - device code: difficult to remove.
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Manufacturer Narrative
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E1 - initial reporter city: (b)(4).Device code: difficult to remove.Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination identified that the balloon was not folded which indicates that the it was subjected to positive pressure.Blood was identified inside the inflation lumen which is evidence of a device leak.A microscopic examination identified a balloon longitudinal tear beginning approximately 1mm distal of the proximal markerband and extending approximately 4mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is (b)(4) atmospheres as per 2cm pcb specification.A microscopic examination found one of the blades of the device to be completely detached from the device.The blade pad remained fully bonded to the balloon material.The detached blade was not returned for analysis.All other blades and blade pads were undamaged and fully bonded to the balloon material.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found the no damage or kinks in 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 the blade was detached and dislodged inside the patient's body.The 75% stenosed target lesion was located in the upper arm shunt vessel.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure, after shunt dilatation was completed, the device was removed, but there was resistance felt.The balloon was returned into the vessel then it was rotated and then removed.However, during bailout procedure, it was noted that one blade on the balloon was missing.When it was extracted by echo near the sheath, it was confirmed that the blade was attached on the tip of the sheath.The physician revealed that the angle of the sheath tip was not good.The missing balloon blade might be left inside the patient's body.No additional intervention or treatment was performed.The procedure was completed with the same device.No patient complications reported and patient status was stable.
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