Catalog Number 9-AVP2-022 |
Device Problems
Fracture (1260); Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895); Separation Problem (4043)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 01/09/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that on (b)(6) 2024, 22mm amplatzer vascular plug ii was chosen for implant into the left internal iliac artery using a 7f non- abbott delivery system.The device was properly prepared per the instructions for use (ifu).During procedure, the plug would not detach from the wire with multiple attempts of torqueing the wire counter clockwise.With continued torqueing, the wire eventually fractured leaving approximately 3cm of wire still attached to the plug.The plug was deployed in a good position in the patient body.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported discharged.
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Manufacturer Narrative
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An event of separation problem with multiple attempts of torquing the wire counter clockwise, and fractured wire due to continued torquing was reported.Also reported that approximately 3 cm of wire was still attached to the plug which was deployed in a good position in the patients body.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, " if the device position is satisfactory: - attach the plastic vise to the wire, and release the device by rotating the delivery wire counterclockwise until it separates from the device.- remove the delivery catheter and wire from the patient.".
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Search Alerts/Recalls
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