BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 3822 |
Device Problems
Leak/Splash (1354); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter name and address: (b)(6).The device was returned for evaluation.A visual examination identified that the balloon was in a relaxed state with evidence of solidified blood inside the balloon material.The device was placed in the water bath at 37 degrees to allow the solidified blood inside the balloon body to soften to aid an inflation attempt.The device was attached to encore inflation device and during an attempt to inflate the balloon, a balloon pinhole leak was confirmed over the proximal markerband.A visual and microscopic examination observed no damage to the markerbands, tip or blades.All blades were present and fully bonded to the balloon surface.No damage or any issues were noted with the markerbands, blades or tip that could have contributed to the complaint incident.A visual and tactile examination found no issues with the hypotube shaft.A visual and tactile examination found that there were no issues with the extrusion shaft.No other issues were identified with the returned device during the product analysis.
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Event Description
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Reportable based on device analysis completed on 25jun2021.It was reported that crossing difficulties and balloon leak occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery which included a significant bend.A 10/3.25 flextome cutting balloon was selected for use.During the procedure, the balloon could not cross the lesion.The balloon was inflated once at 6 atmospheres and a leak was noted.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed a balloon pinhole.
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Search Alerts/Recalls
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