Catalog Number DFS10051020 |
Device Problem
Impedance Problem (2950)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/10/2011 |
Event Type
malfunction
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Event Description
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The complaint received sates that during use the deltapaq platinum microcoil 5 mm x 10 cm (dfs10051020 / f57686) was impeded in the microcatheter.The coil would not track through the micro catheter.The coil was then successfully completely removed and set aside for return to micrus.Many additional coils were then successfully implanted.The mc was not able to be saved for return.There was no report of injury to the patient.
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Manufacturer Narrative
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This mdr is being submitted as part of retrospective review as a result of a recent fda audit and with accordance to the requirements of code of federal regulations ¿ 21 cfr part 803, medical device reporting.The complaint received sates that during use the deltapaq platinum microcoil 5 mm x 10 cm (dfs10051020 / f57686) was impeded in the microcatheter.The coil would not track through the micro catheter.The coil was then successfully completely removed and set aside for return to micrus.Many additional coils were then successfully implanted.The mc was not able to be saved for return.There was no report of injury to the patient.The coil was returned severely damaged.The evidence strongly suggests that interference inside the microcatheter most likely contributed to the coils resistance.The source and location of this interference cannot be determined.It also cannot be determined if this interference was of a fixed or detached nature.In addition; without the return of the sl-10 microcatheter used in the procedure; it cannot be determined if this component contributed to the complaint event.The complaint was confirmed on analysis.100% inspections are in place to prevent damaged products from leaving the facility and the dhr review confirmed that the product met specifications.No corrective action is required at this time.Review of the information suggests that procedural issues may have contributed to the confirmed event.
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Search Alerts/Recalls
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