Model Number H74939135304010 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that shaft break occurred.A 3mm x 40mm x 146cm coyote es balloon catheter was advanced but would not go further.Upon removal, the catheter broke somewhere on the femoral artery and so the balloon tip and balloon itself was left inside the patient.The device was then removed surgically.No patient complications were reported and the patient's status was fine and okay.
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Manufacturer Narrative
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Device evaluated by manufacturer: returned device consisted of a coyote es balloon catheter.The balloon was tightly folded with blood and contrast in the hub and lumen, with blood on the balloon.Microscopic inspection of the balloon and markerband found no irregularities or defects.Microscopic inspection found no irregularities with the bond of the device.Microscopic inspection of the tip found no irregularities or defects.Microscopic and tactile inspection revealed numerous kinks in the hypotube and distal shaft.There was a separation in the hypotube 92cm from the strain relief.The fracture faces were oval, suggesting the area was kinked prior to separating.The manufacturing batch record review confirmed that 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 shaft break occurred.A 3mm x 40mm x 146cm coyote es balloon catheter was advanced but would not go further.Upon removal, the catheter broke somewhere on the femoral artery and so the balloon tip and balloon itself was left inside the patient.The device was then removed surgically.No patient complications were reported and the patient's status was fine and okay.
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Search Alerts/Recalls
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