BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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Model Number 3851 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/24/2023 |
Event Type
malfunction
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Event Description
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It was reported that the balloon got stuck with the guidewire.A 10mmx3.00mm wolverine coronary cutting balloon was selected for percutaneous transluminal coronary angioplasty (ptca).During the procedure, when the physician tried to advance the balloon on the guidewire, the balloon got stuck on the wire and the physician could not advance the balloon.The balloon was removed normally without any further intervention and the procedure was completed with a different device.No complications were reported, and the patient was stable after the procedure.
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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 the balloon got stuck with the guidewire.A 10mmx3.00mm wolverine coronary cutting balloon was selected for percutaneous transluminal coronary angioplasty (ptca).During the procedure, when the physician tried to advance the balloon on the guidewire, the balloon got stuck on the wire and the physician could not advance the balloon.The balloon was removed normally without any further intervention and the procedure was completed with a different device.No complications were reported, and the patient was stable after the procedure.
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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 product analysis.A visual and tactile examination of the hypotube shaft identified no damages.A visual examination of the distal extrusion identified that the distal extrusion was severely bunched and accordioned at the balloon area.Microscopic examination of the distal extrusion, including the inner/wire lumen, identified that the extrusion was stretched, bunched and accordioned.This damage was located just proximal from the distal tip end it extended proximally for approximately 4.4cm in length.The inner/wire lumen inside the balloon was severely bunched.A detailed microscopic examination of the balloon identified that the proximal sleeve of the balloon was inverted, inside the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the tip found that the distal edge of the tip was flared.A device-to-device interaction test was performed, and it was not possible to load a recommended 0.014-inch size wire through the wire lumen due to the severe bunching in the distal extrusion.No other issues were identified during the product analysis.
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