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Model Number M001FG000240 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/22/2014 |
Event Type
malfunction
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Event Description
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Reportable based on investigation completed on 08dec2014.It was reported that the tip of the catheter was flattened or damaged.The 100% stenosed target lesion was located in the moderately tortuous and calcified superficial femoral artery.During a peripheral percutaneous intervention (ppi), an atlantis¿ 018 imaging catheter was used in order to visualize the target lesion.However, it was noted that the tip of the device was flattened or damaged.Subsequently, a non-bsc guide wire was unable to pass through the imaging catheter.The procedure was then completed using a different device.No patient complications were reported and the patient's status is good.However, after device analysis it was found out that the distal tip assembly was broken and missing.
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Manufacturer Narrative
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Age at the time of event: 18 years or older.(b)(4).The complaint device was received for evaluation.After device analysis, the following were observed: a kink was observed in the sheath assembly at 20.0cm from femoral marker to the distal end.The distal tip assembly was broken off and missing approximately 3.0mm long during investigation.The broken distal tip assembly appeared stretched and neckdown was observed at the ro marker distal end.During image characterization testing in the roller coaster model, a good square image appeared in the system and the product performed within specification.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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Search Alerts/Recalls
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