Model Number M00545180 |
Device Problems
Break (1069); Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2022 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that an autotome rx 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire jumped off while energizing the device to perform sphincterotomy.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.A photo of the complaint device outside the patient was provided by the customer and shows the cutting wire was broken and kinked, and the plastic catheter tip was damaged.
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a device analysis of 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 an autotome rx 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire jumped off while energizing the device to perform sphincterotomy.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.Note: a photo of the complaint device outside the patient was provided by the customer and shows the cutting wire was broken and kinked, and the plastic catheter tip was damaged.
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Manufacturer Narrative
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Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h6 (evaluation conclusion codes): evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a device analysis of could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11 (correction): section g2 (report source (other) has been updated.
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Search Alerts/Recalls
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