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

Model Number	M00568530
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
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 a feeding tube replacement procedure on (b)(6) 2020.According to the complainant, on (b)(6), 2020, patient was hospitalized due to reflux of stomach contents and nutrients that occurred.The physician attributes the reflux to the malfunction of the device.The device was replaced with a new endovive one step button.
Additional Manufacturer Narrative
Block h6 (device codes): problem code 2978 captures the reportable event of blockage in the button causing the reflux of stomach contents.Block h10: a visual examination of the revealed that there is no visual damage on the complaint device.The obturator was inserted inside the device and no issues were found.Based on the information available and the analysis performed, the unit returned did not show evidence of either the alleged issue or any defect that could have contributed to the event reported, therefore, it was concluded that the investigation conclusion code of this event will be documented as no problem detected since the device complaint or problem cannot be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available this device was used per the directions for use (dfu).
Event or Problem Description
It was reported to boston scientific corporation that an endovive one step button was used during a feeding tube replacement procedure on (b)(6), 2020.According to the complainant, on (b)(6), 2020, patient was hospitalized due to reflux of stomach contents and nutrients that occurred.The physician attributes the reflux to the malfunction of the device.The device was replaced with a new endovive one step button.

• Brand Name: ENDOVIVE ONE STEP BUTTON
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10232541
• Report Number: 3005099803-2020-02611
• Device Sequence Number: 11536416
• Product Code: KGC
• UDI-Device Identifier: 08714729149941
• UDI-Public: 08714729149941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: 09/19/2022
• Device Model Number: M00568530
• Device Catalogue Number: 6853
• Device Lot Number: 0024537655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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: Hospitalization
• Patient Age: 84 YR