Model Number 7585 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Age at the time of event: 18 years or older.
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Event Description
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It was reported that shaft break occurred.A 2.00mm x 15mm maverick 2 balloon catheter was selected for a coronary angioplasty procedure in the right coronary artery (rca).During unpacking, it was noted that the shaft was broken.The procedure was completed with a different device.No patient complications were reported and the patient was stable.
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Manufacturer Narrative
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Age at the time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter.The hypotube was separated 73.5cm from the hub, the separated ends were ovaled indicating that the hypotube was kinked prior to separation.There were numerous kinks throughout the hypotube.The reported separation was confirmed.
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Event Description
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It was reported that shaft break occurred.A 2.00mm x 15mm maverick 2 balloon catheter was selected for a coronary angioplasty procedure in the right coronary artery (rca).During unpacking, it was noted that the shaft was broken.The procedure was completed with a different device.No patient complications were reported and the patient was stable.
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Search Alerts/Recalls
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