BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number 24628 |
Device Problems
Difficult to Remove (1528); Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.
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Event Description
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It was reported that removal resistance was experienced and the blade was bent.A 80% stenosed target lesion was located in moderately tortuous left forearm artery.A 5.00mm / 2.0cm / 50cm 2cm peripheral cutting balloon was selected for use.During the procedure, at first inflation, it was noted that there was still remaining stenosis after preforming the treatment.The guidewire passed through smoothly and so this device was prepared, then the position was checked under fluoroscopy.The partial stenosis remained at 4 atm, so the pressure was applied slowly up to 6 atm for 30 seconds, then it was dilated completely.When the pressure was reduced slowly, it was confirmed that contrast media was completely taken out from the balloon.Device removal was attempted, but severe resistance was felt at the tip of the sheath.The device was checked under fluoroscopy and was suspected that the condition of the wrapping was not good.Dilation was performed at low pressure at the same area with space, then deflation was performed and pulled in the sheath again.Resistance was slightly resolved, still remained around where the balloon was pulled inside the sheath halfway.The device was removed together with the sheath.After checking the device it was noted that there was deformation on some blades.There was no adverse damage to the patient.
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Event Description
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It was reported that removal resistance was experienced and the blade was bent.A 80% stenosed target lesion was located in moderately tortuous left forearm artery.A 5.00mm / 2.0cm / 50cm 2cm peripheral cutting balloon was selected for use.During the procedure, at first inflation, it was noted that there was still remaining stenosis after preforming the treatment.The guidewire passed through smoothly and so this device was prepared, then the position was checked under fluoroscopy.The partial stenosis remained at 4 atm, so the pressure was applied slowly up to 6 atm for 30 seconds, then it was dilated completely.When the pressure was reduced slowly, it was confirmed that contrast media was completely taken out from the balloon.Device removal was attempted, but severe resistance was felt at the tip of the sheath.The device was checked under fluoroscopy and was suspected that the condition of the wrapping was not good.Dilation was performed at low pressure at the same area with space, then deflation was performed and pulled in the sheath again.Resistance was slightly resolved, still remained around where the balloon was pulled inside the sheath halfway.The device was removed together with the sheath.After checking the device it was noted that there was deformation on some blades.There was no adverse damage to the patient.
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Manufacturer Narrative
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Age at time of event: 18 years or older.Updated lot number, expiration date and unique identifier (udi) #.
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Manufacturer Narrative
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Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for analysis.The sheath used by the customer was returned for analysis.On analysis the investigator was unable to advance the device through a 6fr boston scientific introducer sheath due to a hole in the balloon material and a partially detached blade.The customer's sheath was split along its entire length.A visual and microscopic examination was performed on the returned device.It was noted that approximately 17mm of one of the blades and it is blade pad was lifted from the balloon material.The remaining 3mm of the lifted blade and its pad remained bonded to the balloon material.The damage identified 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.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a balloon pinhole located approximately 4mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.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 shaft to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the product analysis.No other issues were identified during the product analysis.
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Event Description
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It was reported that removal resistance was experienced and the blade was bent.A 80% stenosed target lesion was located in moderately tortuous left forearm artery.A 5.00mm / 2.0cm / 50cm 2cm peripheral cutting balloon was selected for use.During the procedure, at first inflation, it was noted that there was still remaining stenosis after preforming the treatment.The guidewire passed through smoothly and so this device was prepared, then the position was checked under fluoroscopy.The partial stenosis remained at 4 atm, so the pressure was applied slowly up to 6 atm for 30 seconds, then it was dilated completely.When the pressure was reduced slowly, it was confirmed that contrast media was completely taken out from the balloon.Device removal was attempted, but severe resistance was felt at the tip of the sheath.The device was checked under fluoroscopy and was suspected that the condition of the wrapping was not good.Dilation was performed at low pressure at the same area with space, then deflation was performed and pulled in the sheath again.Resistance was slightly resolved, still remained around where the balloon was pulled inside the sheath halfway.The device was removed together with the sheath.After checking the device it was noted that there was deformation on some blades.There was no adverse damage to the patient.
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