Model Number H74939277665110 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/12/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the sheath broke.Vascular access was obtained via the right groin.The target lesion was located in the superficial femoral artery (sfa).A chariot guiding sheath was placed.Angioplasty and stent placement were performed.At the end of the procedure, as the physician was coming out, the chariot sheath broke in half leaving half still inside the patient as they were pulling it out.They went ahead and kept pulling the inner wiring of the sheath.When the rest of the device became visible, they grabbed a hemostat to pull the remaining portion of the sheath out of the patient.No patient complications were reported and the patient's status is fine.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a chariot guide sheath.There was blood on the outside and inside the device.Microscopic examination revealed a kink about.5mm from the hub and a kink 15.5cm from the tip.The shaft was detached 18cm from the tip with but still attached by the coil.The coil was stretched proximally 32cm between the shaft separations.The shaft was also damaged on the separated end of the distal half of the separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Event Description
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It was reported that the sheath broke.Vascular access was obtained via the right groin.The target lesion was located in the superficial femoral artery (sfa).A chariot guiding sheath was placed.Angioplasty and stent placement were performed.At the end of the procedure, as the physician was coming out, the chariot sheath broke in half leaving half still inside the patient as they were pulling it out.They went ahead and kept pulling the inner wiring of the sheath.When the rest of the device became visible, they grabbed a hemostat to pull the remaining portion of the sheath out of the patient.No patient complications were reported and the patient's status is fine.
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Search Alerts/Recalls
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