BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7312 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2021 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.A percutaneous coronary intervention was being performed.The 90% stenosed, greater than 30mmx 2.50-3.75mm,concentric, de novo target lesion was located at the moderately tortuous and moderately calcified left anterior descending artery.Following predilation with a 2.00x15mm balloon catheter residual stenosis was 60%.A 3.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, it was noted that shaft of the balloon broke into 2 pieces about 20cm from the proximal hub.The procedure was completed with a different device.There was no patient injury reported and the patient status was stable.
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Manufacturer Narrative
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Returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.The hypotube of the device has numerous kinks.There was a hypotube separation 67.2cm from the strain relief.There was contrast in the inflation lumen and the balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that shaft break occurred.A percutaneous coronary intervention was being performed.The 90% stenosed, greater than 30mmx 2.50-3.75mm,concentric, de novo target lesion was located at the moderately tortuous and moderately calcified left anterior descending artery.Following predilation with a 2.00x15mm balloon catheter residual stenosis was 60%.A 3.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, it was noted that shaft of the balloon broke into 2 pieces about 20cm from the proximal hub.The procedure was completed with a different device.There was no patient injury reported and the patient status was stable.
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Search Alerts/Recalls
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