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

Model Number	M00568520
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr 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.The procedure is unknown.According to the complainant, during the procedure, when the physician released the one step button, it broke.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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.The procedure is unknown.According to the complainant, during the procedure, when the physician released the one step button, it broke.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3 (date of event): date of event was approximated to 05/01/2020 as no event date was reported.Block h6 (device codes): problem code 2907 captures the reportable event of one step button detached.Block h10: visual examination of the returned device revealed that one step button was broken in two pieces and pull wire was bent.The complaint was confirmed.It is most likely that procedural factors encountered during procedure could have affected the device performance and its integrity.Probably the tubing was detached due to user technique, patient anatomy or other procedural factors.As per visual analysis it is confirmed that the delivery system was broken, some additional force applied during the procedure while trying to release the dome or when they tried to insert the unit into the patient could cause the device to stretched and it broke.Based on the information available and the analysis performed, it was determined that the investigation conclusion code for the complaint will be documented as adverse event related to procedure since the event occurred during the preparation and the device had no influence on the event.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.).

• Brand Name: ENDOVIVE ONE STEP BUTTON
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 10097297
• Report Number: 3005099803-2020-02071
• Device Sequence Number: 19679930
• Product Code: KGC
• UDI-Device Identifier: 08714729149231
• UDI-Public: 08714729149231
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: M00568520
• Device Catalogue Number: 6852
• Device Lot Number: 0022638148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1