Model Number M00563030 |
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 Date 04/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 endovive one step button was used during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the pull wire detached from the one step button tube and fell off in the stomach.The detached portion was retrieved using a snare.Reportedly, patient went to surgery to have different feeding tube placed.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.
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Manufacturer Narrative
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A visual examination of the returned device revealed that the catheter was separated into two pieces, confirming the complaint.The damaged section of the catheter appeared elongated.It is likely that excessive tension resulted in the damage.It was noted that the condition of the returned unit was consistent with the complaint incident the button tube delivery system became detached/separated.Based on all gathered information, the complaint investigation conclusion code selected is operational context, which indicates that the complaint is associated with a product that meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.A labeling review was performed and there is no evidence that the device was not used in accordance with the labeling.
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Event Description
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It was reported to boston scientific corporation that an endovive one step button was used during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the pull wire detached from the one step button tube and fell off in the stomach.The detached portion was retrieved using a snare.Reportedly, patient went to surgery to have different feeding tube placed.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.
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Search Alerts/Recalls
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