BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24691 |
Device Problems
Break (1069); Difficult to Remove (1528); Material Rupture (1546); Stretched (1601); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that removal difficulties, balloon rupture, and shaft break occurred.The patient underwent percutaneous transluminal angioplasty (pta) for graft occlusion after bypass from the superficial femoral artery to the popliteal.The stenosed target lesion was located in the moderately tortuous and non calcified below the knee vessel.A 4f introducer sheath was positioned.After crossing the wire, the anterior tibial artery (ata) and posterior tibial artery (pta) were dilated with 2.0 x 4 coyote balloon catheter.A 4mm x 40mm x 146cm coyote es balloon catheter was then used to dilate the trunk section.There was no resistance noted during balloon delivery.The 4mm x 40mm x 146cm coyote es balloon catheter was deflated and there was resistance noted during removal of the balloon catheter from the lesion.At that time, the 4mm x 40mm x 146cm coyote es balloon catheter ruptured and the shaft broke.The introducer sheath was changed to 6f, and the separated 4mm x 40mm x 146cm coyote es balloon catheter was retrieved with a snare.In retrieving the 4mm x 40mm x 146cm coyote es balloon catheter, the shaft was elongated and twisting was also observed.The procedure was completed and no patient complications nor injuries were reported.
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Event Description
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It was reported that removal difficulties, balloon rupture, and shaft break occurred.The patient underwent percutaneous transluminal angioplasty (pta) for graft occlusion after bypass from the superficial femoral artery to the popliteal.The stenosed target lesion was located in the moderately tortuous and non calcified below the knee vessel.A 4f introducer sheath was positioned.After crossing the wire, the anterior tibial artery (ata) and posterior tibial artery (pta) were dilated with 2.0 x 4 coyote balloon catheter.A 4mm x 40mm x 146cm coyote es balloon catheter was then used to dilate the trunk section.There was no resistance noted during balloon delivery.The 4mm x 40mm x 146cm coyote es balloon catheter was deflated and there was resistance noted during removal of the balloon catheter from the lesion.At that time, the 4mm x 40mm x 146cm coyote es balloon catheter ruptured and the shaft broke.The introducer sheath was changed to 6f, and the separated 4mm x 40mm x 146cm coyote es balloon catheter was retrieved with a snare.In retrieving the 4mm x 40mm x 146cm coyote es balloon catheter, the shaft was elongated and twisting was also observed.The procedure was completed and no patient complications nor injuries were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a coyote balloon.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks in the shaft.Additional damage included a prolapsed balloon, stretched shaft 25-37.5cm from the tip, a shaft break at 37.5cm from the tip, a broken guidewire lumen at 25.5cm from the tip, and a burst inflation lumen at the same location as the broken lumen.The balloon was inflated and contained blood, indication the device had been used.Microscopic inspection of the remainder of the device showed no signs of additional damage to the device.E1.Initial reporter city: (b)(6).
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