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	11/09/2016
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 a one step button initial placement gastrostomy kit was used during an esophagogastroduodenoscopy (egd) with peg placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, as the tube was being pulled to the stoma site, the catheter sheath broke inside the patient.Everything was retrieved and no parts of the device were left inside the patient.The procedure was completed with a new one step button initial placement gastrostomy kit.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 no harm to the patient.
Additional Manufacturer Narrative
A visual examination of the returned device revealed that the device had separated into two pieces.The sheath was split as though by a sharp object.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 most probable root cause is "operational context".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 a one step button initial placement gastrostomy kit was used during an esophagogastroduodenoscopy (egd) with peg placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, as the tube was being pulled to the stoma site, the catheter sheath broke inside the patient.Everything was retrieved and no parts of the device were left inside the patient.The procedure was completed with a new one step button initial placement gastrostomy kit.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 no harm to the patient.

• 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: 6137712
• Report Number: 3005099803-2016-03661
• Device Sequence Number: 1248969
• Product Code: KGC
• UDI-Device Identifier: 08714729284161
• UDI-Public: (01)08714729284161(17)20171130(10)18851017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/10/2016

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: 11/30/2017
• Device Model Number: M00563030
• Device Catalogue Number: 6303
• Device Lot Number: 18851017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 02/22/2017
• 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