BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7010 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr.: the 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 47.3cm distal of the strain relief.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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Reportable based on device analysis completed on 22-oct-2020.It was reported that balloon damage occurred.During preparation of a 2.75mm x 12mm quantum maverick balloon catheter, it was noted that the balloon was damaged.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed a detached shaft.
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