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Model Number 606-S255X |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.Device manufacturer date - not available at this time.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2019-01034.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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Event Description
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As reported by a healthcare professional, during a stent-coil embolization, a 4.5mmd 37mml enterprise stent delivery system (enc453700, 11175281) could not advance in the 150/5cm prowler select plus microcatheter (606s255x, 30254238).The physician withdrew the stent and microcatheter (mc) outside of the patient together.The cerebral target position was lost.There was no patient injury reported.The procedure was completed with new products.
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Manufacturer Narrative
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Product complaint # pc-(b)(4).Updated sections on this report: section b5, g4, g7, h2, and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received indicated that other devices were successfully used with the prowler select prior to the encountered issue.No additional intervention was needed to remove the devices from the patient.A ¿little bit force¿ was used through the catheter pull back.Adequate flush was been maintained through the devices.The devices were not inspected prior to use.There was no significant clinical prolongation of the procedure due to the event.
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Search Alerts/Recalls
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