BOSTON SCIENTIFIC CORPORATION MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7585 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: the shaft, hypotube, tip and balloon were microscopically and visually examined.There was a complete separation at 72.5cm distal of the strain relief.The balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported difficulties inflating the balloon.
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Event Description
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Reportable based on device analysis completed on 24-mar-2021.It was reported that inflation failure was encountered.The 85% stenosed, 22mm x 4.1mm target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 2.00mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation, the balloon failed to inflate.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed shaft detached.
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