BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number 24630 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/05/2019 |
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 blade was peeled off.The 90% stenosed target lesion was located in moderately tortuous left forearm shunt vein side.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, the balloon was inflated once at 6-10atm for 15 seconds.Consequently, after dilatation of the target lesion, it was noted that a part of the blade was peeled off.The device was simply removed from the patient's body and the balloon was still intact after removal.No components of the device was left inside the patient's body.No patient complications were reported.
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(6).Device evaluated by manufacturer: the device was returned for analysis.The recommended introducer sheath size for this device is a 6f as per 2cm peripheral cutting balloon.The sheath used by the customer was not returned for analysis.Functional analysis revealed the device could not advance through a 6fr boston scientific introducer sheath due to a partially lifted blade.A visual and microscopic examination was performed on the returned device.It was noted that approximately 11mm of one of the blades was lifted from the balloon material.The remaining 9mm of the lifted blade and the whole blade 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, indicating the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied and the balloon was inflated to its rate of burst pressure of 10atm (atmospheres) without issue.A vacuum was then applied.The inflation device was verified at 10atm (atmospheres), before and after use with a calibrated pressure gauge.This inflation to rate of burst pressure of 10atm (atmospheres) was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or 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 no damage or kinks 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 blade was peeled off.The 90% stenosed target lesion was located in moderately tortuous left forearm shunt vein side.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, the balloon was inflated once at 6-10atm for 15 seconds.Consequently, after dilatation of the target lesion, it was noted that a part of the blade was peeled off.The device was simply removed from the patient's body and the balloon was still intact after removal.No components of the device was left inside the patient's body.No patient complications were reported.
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