Model Number M00584040 |
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 Type
malfunction
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Manufacturer Narrative
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(b)(4).Although the suspect device has been received, 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 mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a dreamtome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during preparation the coating of the preloaded guidewire was noted to be peeled and the hydrophilic tip detached exposing the tip of the metal corewire.The procedure was completed using a second dreamtome rx 44.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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A visual examination of the returned tome showed no anomalies or damages.The returned guidewire revealed that the polymer tip separated from the jacket at the dream end.The very tip of the corewire was not exposed.There is no evidence of fracture sections.The complaint is not consistent with the returned guidewire since the very tip of the corewire was not exposed.It is possible that the way in which the device was handled and manipulated during unpacking may have contributed to the failure reported.Therefore, the most probable root cause is handling damage.A dhr (device history record) review was performed and no deviation was found.
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Event Description
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It was reported to boston scientific corporation that a dreamtome¿ rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during preparation the coating of the preloaded guidewire was noted to be peeled and the hydrophilic tip detached exposing the tip of the metal corewire.The procedure was completed using a second dreamtome¿ rx 44.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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