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Model Number H749518080 |
Device Problem
Kinked (1339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/22/2014 |
Event Type
malfunction
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Event Description
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Reportable based on device analysis completed on (b)(4) 2014.It was reported that a kink in the telescope occurred.During the crustaceous coronary intervention (pci) procedure that an opticross¿ imaging catheter was used in order to visualize the unknown target lesion.However, a kink in the telescope of the device was noted.The procedure was then completed with a different device.No patient complications were reported and the patients' status is good.However, after device evaluation, a break at the lap joint assembly was observed.
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Manufacturer Narrative
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Device evaluated by manufacturer: the complaint device was received for evaluation.Evaluation of the returned device revealed that there were no kinks observed along the length of the catheter.The telescope assembly was not able to properly pull back, advance, or retract.The telescope cannot advance the transducer distal housing (tdh) to the most distal position.A break was observed at the lap joint assembly.The imaging window was still partially attached to the blue sheath assembly.Fluid was leaking from the break at the sheath lap joint assembly when the catheter was flushed.No image appeared in the system due to electrical open at proximal.Imaging core windup was found in the telescope assembly.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
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Search Alerts/Recalls
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