Model Number 24658 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (b)(6).
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Event Description
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It was reported that the balloon was damaged.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During the procedure, after opening the device and upon checking the balloon part, it was observed that the proximal part of the balloon was discolored black.The appearance was black and seems burnt.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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E1 - initial reporter address:(b)(6).Device evaluated by mfr: spcb flextome mr- 4.00mm/1.5cm/140cm-ous was received for analysis.An examination of the returned device identified that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.The tip, balloon and markerbands of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.A visual and microscopic examination observed no damage to the blades.All blades were present and fully bonded to the balloon surface.Oxidation of the blades was noted.This is attributed to the blades being exposed to moisture which oxidizes the blades over a period.The device was received inside its protective hoop.Brown oxidation was noted inside the protective hoop which is an indication that the device was exposed to moisture before being placed inside the hoop.No kinks or damage were noted along the shaft of the device.This concludes the product analysis.
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Event Description
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It was reported that the balloon was damaged.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During the procedure, after opening the device and upon checking the balloon part, it was observed that the proximal part of the balloon was discolored black.The appearance was black and seems burnt.The procedure was completed with a different device.No patient complications were reported.
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Search Alerts/Recalls
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