BOSTON SCIENTIFIC CORPORATION WOLVERINE PERIPHERAL CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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Model Number 39345-401510 |
Device Problems
Break (1069); Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2024 |
Event Type
Injury
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Event Description
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It was reported that the catheter separated.Vascular access was obtained utilizing the contralateral approach.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal superficial femoral artery.A 4.00mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, due to the tight angle and bifurcation, the device was pushed and pulled several times when crossing through the stenosis.The balloon failed to inflate on the third inflation.When attempting to pull the shaft of the device back into the guide catheter sheath, separation around the lumen occurred around the tip of the guide catheter sheath and was collected with a snare.The procedure was completed with a different device and there was no patient injury reported.
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Event Description
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It was reported that the catheter separated.Vascular access was obtained utilizing the contralateral approach.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal superficial femoral artery.A 4.00mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, due to the tight angle and bifurcation, the device was pushed and pulled several times when crossing through the stenosis.The balloon failed to inflate on the third inflation.When attempting to pull the shaft of the device back into the guide catheter sheath, separation around the lumen occurred around the tip of the guide catheter sheath and was collected with a snare.The procedure was completed with a different device and there was no patient injury reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the shaft was completely separated at the monorail port.The distal section of the device including the balloon was not returned for analysis.This type of damage is consistent with the applying excessive tensile force to remove the device from the patient, causing device separation.No other issues were identified with the shaft of the device.The distal section of the device including the balloon, blades, markerbands and tip was not returned for analysis.
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Search Alerts/Recalls
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