BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7010 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 06/18/2020 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.A 3.5mm x 12mm quantum maverick balloon catheter was selected for use.However, during preparation, it was noticed that the device was fractured.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 72.7cm distal of the strain relief.There was and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
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Event Description
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It was reported that shaft break occurred.A 3.5mm x 12mm quantum maverick balloon catheter was selected for use.However, during preparation, it was noticed that the device was fractured.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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