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
Leak/Splash (1354); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.
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Event Description
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It was reported that a balloon rupture occurred.Vascular access was via the right femoral artery.The 90% stenosed, 73 x 3.50 mm, concentric, de novo, target lesion was located in the moderately tortuous and severely calcified right coronary artery with a bend >= 90 degrees.Following pre dilatation with a 12 x 2.00mm maverick balloon, there was 65% residual stenosis.When a 10mm x 2.00mm wolverine coronary cutting balloon was advanced to crack the calcium, significant resistance was encountered.On the first inflation of the wolverine balloon at 6atm, the balloon ruptured within less than 10 seconds and blood was leaking from the back side.The device was removed and the procedure completed with another of same device.No patient complications were reported and patient was stable post procedure.
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Event Description
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It was reported that a balloon rupture occurred.Vascular access was via the right femoral artery.The 90% stenosed, 73 x 3.50 mm, concentric, de novo, target lesion was located in the moderately tortuous and severely calcified right coronary artery with a bend >= 90 degrees.Following pre dilatation with a 12 x 2.00mm maverick balloon, there was 65% residual stenosis.When a 10mm x 2.00mm wolverine coronary cutting balloon was advanced to crack the calcium, significant resistance was encountered.On the first inflation of the wolverine balloon at 6atm, the balloon ruptured within less than 10 seconds and blood was leaking from the back side.The device was removed and the procedure completed with another of same device.No patient complications were reported and patient was stable post procedure.
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Manufacturer Narrative
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A2 - age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located at 5mm distal to the proximal marker band.An 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 and tactile examination found no issues with the hypotube of this device.The markerbands and tip of the device were visually and microscopically examined, and damage was noted of the tip of this device.
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