BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7162 |
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 03/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: date of event is unknown.Bsc became aware of the event on (b)(6) 2020.Therefore a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole at the proximal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon damage.
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Event Description
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It was reported that a balloon was damaged.During preparation and while unpacking on the table outside of the patient, it was noticed that three 2.50mm x 12mm emerge balloons were damaged.The procedure was completed with another of the same balloon.No patient complications were reported in relation to this event.However, two of the balloons returned and analysis revealed a pinhole in both balloons.
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