BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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Model Number 83787 |
Device Problems
Difficult to Remove (1528); Stretched (1601)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the device was returned for evaluation.It was observed that the main coil was bent and stretched at the coil arm and primary coil section.Also, the arm coil was detached.The original pouch was returned, and it was observed that the pouch information matches with the complaint information.The functional could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.
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Event Description
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Reportable based on device analysis completed on 27feb2024.It was reported that the catheter could not be retracted when the coil was retracted, and the device was stretched.The target lesion was located in the internal iliac artery.A 20mm x 40cm interlock-35 was selected for use.The catheter could not be retracted when the coil was retracted, and the device was stretched.The entire contrast catheter was withdrawn with the coil.The procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the arm coil was detached.
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