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Model Number M00510880 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Although the suspect device has been received for analysis, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental a mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during a biliary stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after the guidewire was passed through, the trapezoid rx basket was inserted.On the endoscope screen, a green object was found attached/adhered on the tip part of the basket.The device was removed and another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during a biliary stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after the guidewire was passed through, the trapezoid rx basket was inserted.On the endoscope screen, a green object was found attached/adhered on the tip part of the basket.The device was removed and another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Device code 2944 captures the reportable event of foreign material present in device.Visual inspection of the returned device found green residues attached/adhered in the tip of the basket.No other issues with the device were noted.Ftir analysis of the green material found that it was a 94.78% spectral match with fatty alkanolamide and 94.14% match with cochineal, a food coloring substance.These results indicate that the foreign matter is organic material and likely a food coloring substance that adhered to the device during the procedure and inside the patient.Additionally, a review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Therefore, based on all available information, the investigation concluded that the most probable root cause of the event is adverse event related to procedure.
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Search Alerts/Recalls
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