Model Number M00545000 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an rx cytology brush was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, the wire inside the catheter broke.There were no known patient complications reported as a result of this event.
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Manufacturer Narrative
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Investigation results.Visual evaluation of the returned device revealed that the catheter was kinked in multiple locations throughout.The pull wire was found cut at the distal end by the customer and the bristled portion of the brush was not present and was not returned for evaluation.Functional analysis showed that the handle failed to extend and the device was disassembled, they found that the pull wire was kinked and broken at the hypotube joint.Due to anatomical/procedural factors encountered during the procedure; performance of the device was limited.Therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record (dhr) was performed and no deviations were found.
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Event Description
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It was reported to boston scientific corporation that an rx cytology brush was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, the wire inside the catheter broke.There were no known patient complications reported as a result of this event.
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Search Alerts/Recalls
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