BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number 24630 |
Device Problems
Deflation Problem (1149); 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 07/29/2021 |
Event Type
malfunction
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Event Description
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It was reported that the blade was partially detached.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified arteriovenous fistula.A 7.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During withdrawal, the device was removed intact from the patient's body but the blade was partially detached.Furthermore, it was noted that maybe the balloon was not deflated.The sheath was checked at the end of procedure and there was no evidence of cutting or any deformation.There were no patient complications reported.
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Manufacturer Narrative
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H6: removed device code: deflation problem.Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination was performed on the returned device.It was noted that approximately 18mm of one section of blade was lifted from its distal end from the balloon material.The remaining 1mm of the blade and 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 through the sheath.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 device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied, the balloon was inflated to its rate of burst pressure of 10 atmospheres for 30 seconds using glycerol/water and digital timer without issue.No issues were noted with the balloon material of the device upon inflation.The inflation device was verified at 10 atmospheres, before and after use with calibrated pressure gauge.A vacuum was then applied.The balloon of the device deflated within 20 seconds which was timed using a digital timer.The deflation time of the device as per product specification should be less than or equal to 30 seconds.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 issues with 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 partially detached.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified arteriovenous fistula.A 7.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During withdrawal, the device was removed intact from the patient's body but the blade was partially detached.Furthermore, it was noted that maybe the balloon was not deflated.The sheath was checked at the end of procedure and there was no evidence of cutting or any deformation.There were no patient complications reported.It was further clarified that sufficient time may not have been allowed, for the balloon to fully deflate, prior to withdrawal attempts.
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Search Alerts/Recalls
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