Model Number 3851 |
Device Problems
Contamination (1120); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1 - initial reporter address 1: (b)(6).
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Event Description
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It was reported that device contamination occurred.A 10mmx2.25mm wolverine coronary cutting balloon was selected for percutaneous coronary intervention (pci).During withdrawal, it was noted that there was something pointy near the exit port of the device and the gloves were damaged.Upon further checking, it was a piece of plastic that seemed to have come off when the glove was damaged.The procedure was completed using this device.There was no damage to the human body and no health problems.
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Manufacturer Narrative
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E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for analysis along with a latex glove and some gauze.A visual and tactile examination of the hypotube shaft profile identified no kinks or damages.A visual and tactile examination of the distal extrusion identified no damages.A detailed microscopic examination of the balloon material identified no damages.The balloon was not tightly folded and did not exhibit any signs of device use.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the guidewire exit port and entire distal extrusion, did not identify any damages.A microscopic examination of the tip section found no damages.A finger section in the glove was marked out with arrows in blank ink.A detailed microscopic examination of this section of glove identified no tears or damages to the glove.A visual and microscopic examination of the gauze did not find any foreign material attached to the gauze.A recommended 0.014 inch size wire was inserted through the tip and wire lumen with no resistance noted.The guidewire exited out through the guidewire exit port with no resistance noted.No other issues were identified during the product analysis.
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Event Description
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It was reported that device contamination occurred.A 10mmx2.25mm wolverine coronary cutting balloon was selected for percutaneous coronary intervention (pci).During withdrawal, it was noted that there was something pointy near the exit port of the device and the gloves were damaged.Upon further checking, it was a piece of plastic that seemed to have come off when the glove was damaged.The procedure was completed using this device.There was no damage to the human body and no health problems.
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Search Alerts/Recalls
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