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Model Number H74939202100540 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/06/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: mid 70s.Device evaluated by mfr: the device was returned for analysis with a 0.014inch guidewire which was inserted through the balloon catheter and microcatheter.Device analysis revealed a pinhole rupture in the shaft and a punctured hole in the wall of the shaft at 45.5cm distal to the strain relief.An attempt to remove the microcatheter from the balloon catheter failed.A build-up of solidified blood was present on the surface of the shaft.An examination of the lumen of the balloon catheter could not identify any anomalies which could potentially have contributed to this incident.The device was soaked in 37 degrees water; however, it could not be withdrawn.As a result, the shaft was dissected and the microcatheter was removed.No issues were noted with the tip profile of the microcatheter.No other issues or defects were observed during product analysis of the returned device.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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Reportable based on device analysis completed on 28apr2016.It was reported that the microcatheter failed to track to re-entry site.The target lesion was located in the left superficial femoral artery (sfa).An offroad¿ re-entry microcatheter was selected for use.During the procedure, the offroad¿ re-entry microcatheter was delivered to reenter the target lesion though a 0.035 inch non-bsc guidewire.When the offroad¿ re-entry microcatheter was in placed, the physician pulled the 0.035 inch non-bsc guidewire out and tried to advance a.014 inch non-bsc guidewire with a trochar.However, the trochar could not passed halfway up to the left common iliac.Several attempts were made but failed.The physician opted to pull everything out from the patient and aborted the procedure.No patient complications were reported and the patient's status is fine.However, device analysis revealed a pinhole rupture in the shaft and a punctured hole in the wall of the shaft at 45.5cm distal to the strain relief.
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Search Alerts/Recalls
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