Model Number 3852 |
Device Problems
Detachment of Device or Device Component (2907); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address (b)(6).
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Event Description
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It was reported that device contamination occurred.The 90% stenosed target lesion was located in the left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, while performing percutaneous transluminal coronary angioplasty (ptca), they opened the 15mmx2.50mm wolverine coronary cutting balloon and after opening some starches were observed on the shaft.Then, after trying to advance the catheter balloon through the hub it got damage.There were no patient complications reported.
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Manufacturer Narrative
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E initial reporter address (b)(6).H6: updated device code.
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Event Description
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It was reported that some starches was seen on the shaft.The 90% stenosed target lesion was located in the left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, while performing percutaneous transluminal coronary angioplasty (ptca), they opened the 15mmx2.50mm wolverine coronary cutting balloon and after opening some starches was seen on the shaft.Then, after trying to advance the catheter balloon through the hub it got damage.There were no patient complications reported.It was further reported that the hub was kinked and then got broken.
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Manufacturer Narrative
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E.Initial reporter address 1: (b)(6) h6: updated device code.
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Event Description
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It was reported that some starches was seen on the shaft.The 90% stenosed target lesion was located in the left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, while performing percutaneous transluminal coronary angioplasty (ptca), they opened the 15mmx2.50mm wolverine coronary cutting balloon and after opening some starches was seen on the shaft.Then, after trying to advance the catheter balloon through the hub it got damage.There were no patient complications reported.It was further reported that the hub was kinked and then got broken.In addition, after attempting to advance the wolverine device through the hub of a guide catheter, the balloon shaft got damaged in the form of scratch.
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Manufacturer Narrative
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E.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was in a deflated state.No issues were noted with the balloon of the device that may have potentially contributed to the complaint incident.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.The device was received in two sections as a result of a break in the hypotube.The break was located at 22.5 cm distal to the strain relief.Both sections of the hypotube were kinked at various locations.This type of damage is consistent with excessive force that could have been applied to the delivery system.A detailed microscopic examination of both sections of hypotube identified no foreign material or staining adhering to the hypotube shaft.A visual and tactile examination of the extrusion shaft found no issues with the extrusion shaft.A detailed microscopic examination of extrusion identified no foreign material or staining adhering to the hypotube shaft.No other issues were identified during the product analysis.
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Event Description
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It was reported that some starches was seen on the shaft.The 90% stenosed target lesion was located in the left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, while performing percutaneous transluminal coronary angioplasty (ptca), they opened the 15mmx2.50mm wolverine coronary cutting balloon and after opening some starches was seen on the shaft.Then, after trying to advance the catheter balloon through the hub it got damage.There were no patient complications reported.It was further reported that the hub was kinked and then got broken.In addition, after attempting to advance the wolverine device through the hub of a guide catheter, the balloon shaft got damaged in the form of scratch.
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Search Alerts/Recalls
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