Model Number 3851 |
Device Problems
Inflation Problem (1310); Material Puncture/Hole (1504); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that a shaft perforation occurred.This 10mmx3.00mm wolverine cutting balloon was selected for a angioplasty procedure.The balloon was unable to be inflated to nominal pressure, as the unspecified guidewire came out from the shaft of the wolverine close to the balloon portion of the device.The procedure was completed with another of the same device.No patient complications were reported.
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Event Description
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It was reported that a shaft perforation occurred.This 10mmx3.00mm wolverine cutting balloon was selected for a angioplasty procedure.The balloon was unable to be inflated to nominal pressure, as the unspecified guidewire came out from the shaft of the wolverine close to the balloon portion of the device.The procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: a 10mm x 3.00mm wolverine cutting balloon was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.All blades were intact within their pads and fully bonded to the balloon material.A visual, microscopic and tactile examination found no kinks along the hypotube.An examination of the distal extrusion identified bunching of the inner /wire lumen at 2.5cm proximal from the proximal balloon cone.Further examinations noted a perforation in the outer extrusion at 2.7cm proximal from the proximal balloon cone.It is likely that as a result of the bunching in the wire lumen, when an attempt was made by the physician to pass the wire through the bunched lumen, it resulted in the guidewire puncturing out through the inner and outer lumen.During an attempt to inflate the balloon liquid leaked out through the perforated hole in the outer.As a result not possible to inflate balloon.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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It was reported that a shaft perforation occurred.This 10mmx3.00mm wolverine cutting balloon was selected for a angioplasty procedure.The balloon was unable to be inflated to nominal pressure, as the unspecified guidewire came out from the shaft of the wolverine close to the balloon portion of the device.The procedure was completed with another of the same device.No patient complications were reported.
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Search Alerts/Recalls
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