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); Leak/Splash (1354); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned for evaluation.A visual examination of the balloon identified no damages.No issues were noted on the hypotube shaft.Visual examination could not identify any kinks or damages in the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.The polymer extrusion appeared to have no issues however, when inflated to rated burst pressure (rbp), pinhole leaks were noted along the polymer extrusion shaft 4cm, 4.9cm and 10cm form the tip of the device.The distal extrusion was dissected, and a microscopic examination of the inner lumen identified no tear or damage.The tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.No other issues were identified during the product analysis.
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Event Description
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Reportable based on device analysis completed on 21sep2023.It was reported that a balloon leak was noted.The 30mm x 3.0-3.5mm, 95% stenosed target lesion was located in the non- tortuous and mildly calcified middle section of left anterior descending artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was dilated at a pressure of 4atm in the patient's body, and it was found that the balloon could not dilate.The balloon was removed and a balloon leak was found in vitro test.The procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.However, device analysis revealed pinhole leaks along the polymer extrusion shaft.
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