BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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Model Number 3851 |
Device Problems
Inflation Problem (1310); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was folded which indicates that the balloon was not subjected to positive pressure.Solidified media was also present inside the balloon material which is indicative of a device leak.The device was placed in the waterbath at 37 degrees celsius in order to allow the media to soften.Once removed, the returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from a balloon pinhole located in the proximal balloon cone.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination identified no issues with the hypotube or shaft polymer extrusion of this device.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.
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Event Description
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Reportable based on device analysis completed on (b)(6) 2022.It was reported that crossing difficulties were encountered.The target lesion was located in a moderately calcified artery.A 10mm x 2.75mm wolverine coronary cutting balloon was selected for use.During procedure, the device was advanced but did not cross the lesion and when inflation was performed, the balloon did not inflate.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed a balloon pinhole.
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