BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number H74939135152010 |
Device Problems
Break (1069); Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546)
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Patient Problems
Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)
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Event Date 11/24/2017 |
Event Type
Injury
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).
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Event Description
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It was reported that removal difficulty, shaft break, balloon deflation failure, balloon rupture and blood flow reduction occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified eccentric posterior tibial artery and distal part with a reference vessel diameter of about 2.0-2.5mm.A 3.3fr non-bsc introducer sheath was placed to the same side of the popliteal artery by ipsilateral antegrade approach, and then two non-bsc guidewires were placed.A non-bsc 2.0-100mm balloon catheter was advanced but unable to cross the lesion.Then a 1.5mmx20mmx143cm coyote balloon catheter was advanced and pre-dilation was performed at 6 atm for 60 seconds.Then the device was caught by the calcification and it could not be moved at all.Thus the distal plantar artery was punctured and a non-bsc guidewire was approached to the tip of the trapped device to try to push it up, but it could not be moved.After that the balloon was inflated up to more than the rated burst pressure to rupture the balloon since the balloon was not fully deflated.But it still could not be removed even after pulling the shaft.About 20cm distal part of the shaft was detached and it remained inside the patient's body.The procedure was ended.Distal bypass surgery is scheduled at a later date due to decrease in blood flow.7 days later surgical operation was performed successfully.The distal part of the posterior tibial artery was opened surgically.The detached balloon and distal tip were removed.Then, bypass graft was performed using the patient¿s vein to the distal part of the posterior tibial artery.The patient¿s status was stable.
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Manufacturer Narrative
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Device evaluated by mfr: returned device consisted of a coyote es balloon catheter in two pieces.There was blood and contrast in the balloon, wire lumen and inflation lumen.The tip, balloon, markerbands, proximal weld, inner/outer shaft, port/exit notch were microscopically, tactile and visually inspected.Inspection revealed; a complete separation (stretched) in the shaft (outer and inner shafts) located just distal of the port/exit notch (24 cm from the tip), numerous kinks in the distal shaft, balloon bunching with the distal end of the balloon prolapsing near the tip, tip damage (stretched/shredded), and port weld damage (stretched/focally necked/top of port ripped).Functional testing could not be performed due to the excessive damage to the device.Inspection of the remainder of the device revealed no other damage or irregularities.The reported information indicates the device was inflated over rated burst pressure.The physician intentionally inflated balloon over rated burst pressure in an effort to remove the device from the patient¿s anatomy.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Event Description
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It was reported that removal difficulty, shaft break, balloon deflation failure, balloon rupture and blood flow reduction occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified eccentric posterior tibial artery and distal part with a reference vessel diameter of about 2.0-2.5mm.A 3.3fr non-bsc introducer sheath was placed to the same side of the popliteal artery by ipsilateral antegrade approach, and then two non-bsc guidewires were placed.A non-bsc 2.0-100mm balloon catheter was advanced but unable to cross the lesion.Then a 1.5mmx20mmx143cm coyote balloon catheter was advanced and pre-dilation was performed at 6 atm for 60 seconds.Then the device was caught by the calcification and it could not be moved at all.Thus the distal plantar artery was punctured and a non-bsc guidewire was approached to the tip of the trapped device to try to push it up, but it could not be moved.After that the balloon was inflated up to more than the rated burst pressure to rupture the balloon since the balloon was not fully deflated.But it still could not be removed even after pulling the shaft.About 20cm distal part of the shaft was detached and it remained inside the patient's body.The procedure was ended.Distal bypass surgery is scheduled at a later date due to decrease in blood flow.7 days later surgical operation was performed successfully.The distal part of the posterior tibial artery was opened surgically.The detached balloon and distal tip were removed.Then, bypass graft was performed using the patient¿s vein to the distal part of the posterior tibial artery.The patient¿s status was stable.
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