Model Number 7585 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/25/2020 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.A 2.50mm x 15mm maverick balloon catheter was selected for use.However, it was noted that the balloon burst before entering into the patient's body.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
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Manufacturer Narrative
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D4: corrected batch lot number from 0022892833 to 0021834643.
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Event Description
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It was reported that balloon rupture occurred.A 2.50mm x 15mm maverick balloon catheter was selected for use.However, it was noted that the balloon burst before entering into the patient's body.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
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Event Description
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It was reported that balloon rupture occurred.A 2.50mm x 15mm maverick balloon catheter was selected for use.However, it was noted that the balloon burst before entering into the patient's body.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
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Manufacturer Narrative
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D4: corrected batch lot number from 0022892833 to 0021834643 device evaluated by mfr: returned product consisted of a maverick 2 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.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 2mm proximal from the distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.
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Search Alerts/Recalls
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