BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON?; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number M001BP90720B0 |
Device Problems
Detachment Of Device Component (1104); Material Puncture/Hole (1504)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Event Description
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It was reported that a blade detachment occurred.A 7.00mm/2.0cm/90cm otw peripheral cutting balloon¿ was selected for treatment.During procedure, when the device was removed from the patient, it was noted that two arms broke puncturing the balloon and one of the blades was detached.They were able to recover all parts upon removal of the sheath.There were no patient complications reported.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Device evaluated by manufacturer.The device was returned for analysis.A visual examination identified that approximately 15 mm of one blade and blade pad had lifted from the balloon's proximal body.However, 3.5 mm of the proximal section of the blade pad was still intact.Additionally, approximately 5 mm of one blade and blade pad had lifted from the balloon's proximal body.However, 1 mm of the proximal section of the blade pad was still intact.Also, an entire blade and blade pad had detached from the balloon.It was noted that the balloon was not folded which subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The device was attached to an encore inflation unit.Positive pressure was applied when a leak was noted.A further microscopic analysis noted a pinhole at 1.5 mm proximal to the proximal end of the distal markerband.A visual and tactile examination found that the hypotube was kinked at various positions along its length.This type of damage is consistent with excessive force being applied to the delivery system during device use/handling.No further damage was noted to the catheter.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Event Description
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It was reported that a blade detachment occurred.A 7.00mm/2.0cm/90cm otw peripheral cutting balloon¿ was selected for treatment.During procedure, when the device was removed from the patient, it was noted that two arms broke puncturing the balloon and one of the blades was detached.They were able to recover all parts upon removal of the sheath.There were no patient complications reported.
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Search Alerts/Recalls
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