MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ENDOVIVE¿ ONE STEP BUTTON¿; TUBE, GASTRO-ENTEROSTOMY

Model Number	M00563030
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: ENDOVIVE¿ ONE STEP BUTTON¿
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7494195
• Report Number: 3005099803-2018-01516
• Device Sequence Number: 1313932
• Product Code: KGC
• UDI-Device Identifier: 08714729284161
• UDI-Public: 08714729284161
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: M00563030
• Device Catalogue Number: 6303
• Device Lot Number: 20604355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR