BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00584040 |
Device Problems
Break (1069); Failure to Conduct (1114)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device problem (b)(4) captures the reportable event of cutting wire broken.Evaluation conclusion (b)(4) is being used in lieu of an adequate conclusion code for device not returned.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a device analysis could not be completed.If any further relevant information is identified, a supplemental medwatch 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 in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the physician had difficulty cutting the sphincter and then the cutting wire broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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