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Model Number 48006020S |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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As reported upon opening, the tip of the saber 6mm 2mm 90 was found broken (the tip was found separated).The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the device.There were no difficulty removing the product from the package.The devices stored in the lab in its original packaging and the product was stored for 2-3 days before being distributed to the cath lab.The device was not returned for analysis.A device history record (dhr) review of lot 17051823 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip separated during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the limited information provided, procedural/handling may have contributed to the reported event.According to the instructions for use (ifu), ¿proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.
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Event Description
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As reported upon opening, the tip of the saber 6mm 2mm 90 was found broken (the tip was found separated).The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the device.There were no difficulty removing the product from the package.The devices stored in the lab in it's original packaging and the product was stored for 2-3 days before being distributed to the cath lab. the product will be returned for analysis.
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Manufacturer Narrative
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As reported upon opening, the tip of the saber 6mm 2mm 90 was found broken (the tip was found separated).The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the device.There were no difficulty removing the product from the package.The devices stored in the lab in its original packaging and the product was stored for 2-3 days before being distributed to the cath lab. one non-sterile unit of saber 6mm 20cm 90 was received coiled inside a plastic.Per visual analysis the catheter distal tip was received separated, the distal separated section was not received.No other anomalies or damages were observed.Sem analysis was performed to identify the root cause of the catheter distal tip separation and results showed that the separated area presented elongations and frayed edges.These characteristics presented evidence of an application of a tension force that induced the separation.No other issues were noted during the sem analysis.A device history record (dhr) review of lot 17051823 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip separated during prep¿ was confirmed through analysis of the returned device.However, the exact cause of the reported failure could not be conclusively determined during analysis.Based on the limited information provided, procedural/handling may have contributed to the reported event as evidenced by the presence of elongations and frayed edges at the separated area during sem analysis.According to the instructions for use (ifu), which is not intended as a mitigation, ¿proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the design or manufacturing process of the product.Therefore, no corrective/preventive action will be taken at this time.
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Manufacturer Narrative
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This device was received for analysis but the engineering report is not yet available. however, it will be submitted within 30 days upon receipt.
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Search Alerts/Recalls
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