Model Number 1013465-060 |
Device Problems
Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/18/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device is expected to be returned for investigation.It has not yet been received.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 the procedure was to treat a lesion located in the peroneal artery.The armada 18 balloon catheter was advanced to the lesion without issue, but ruptured during the second inflation at 16 atmospheres and part of the balloon detached on the plaque.A snare device was used to remove the detached portion.A supera stent was implanted to complete the procedure.There was no adverse patient effect and no clinically significant delay reported.No additional information was provided.
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Manufacturer Narrative
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Visual inspection was performed on the returned device.The reported balloon rupture and separations were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.In this case, it was reported that the balloon was inflated a second time to 16 atmospheres.It should be noted that the armada 18 instruction for use (ifu) states: ¿inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.¿ the rated burst pressure for this device is 14 atmospheres as indicated on the product label.In this case, the reported inflation above rbp did not contribute to the ifu violation as the balloon inflated successfully the first time.The investigation determined the reported complaints, additional treatment, removal of foreign body and foreign body in patient appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Event Description
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Subsequent to the previously filed report.It was confirmed that part of the balloon detached; part of the material was able to be removed, but the physician was not able to remove the balloon marker and deployed a supera stent to compress the marker against the artery wall.
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Search Alerts/Recalls
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