Model Number M00521232 |
Device Problems
Premature Activation (1484); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Patient's exact age is unknown; however, it was reported that the patient is at her 60s.Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
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Event Description
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Note: this report pertains to one of three resolution 360 clips used in the same patient and procedure.It was reported to boston scientific corporation that three resolution 360 clip devices were used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the clip was passed down the duodenoscope; however, the clip deployed at the elevator of the scope.The same problem occurred with the second and third resolution 360 clips.The procedure was not completed due to the device was unable to clip the diverticulum in order to access the ampulla.Note: it was reported that the scope used was a duodenoscope.However, per the instructions for use (ifu), hemostasis clip is designed to be compatible with forward viewing endoscopes only.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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Block a2: patient's exact age is unknown; however, it was reported that the patient is at her 60s.Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
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Event Description
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Note: this report pertains to one of three resolution 360 clips used in the same patient and procedure.It was reported to boston scientific corporation that three resolution 360 clip devices were used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the clip was passed down the duodenoscope; however, the clip deployed at the elevator of the scope.The same problem occurred with the second and third resolution 360 clips.The procedure was not completed due to the device was unable to clip the diverticulum in order to access the ampulla.Note: it was reported that the scope used was a duodenoscope.However, per the instructions for use (ifu), hemostasis clip is designed to be compatible with forward viewing endoscopes only.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.Additional information received on april 6, 2023: it was reported that the procedure was performed on (b)(6) 2023.
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Search Alerts/Recalls
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