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

Model Number	M00568520
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 high digestive video endoscopy with percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2020.According to the complainant, during the procedure, the button detached from the sheath prior to being released.The procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes: problem code 2907 captures the reportable event of one step button delivery system detached.The one step button was returned.Visual examination of the returned device found the delivery system was broken however the button had not been deployed.It was determined that some additional force applied during the procedure while trying to release the dome or when they tried to insert the device into the patient could have cause the device to stretch and break.No other issues with the device were noted.With the available information, boston scientific concludes that reported delivery system was broken.Based on the condition of the returned device, engineers determined that there may have been some additional force while trying to release the device or stretching upon insertion of the device which resulted in the delivery system to become broken.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.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an endovive one step button was used during a high digestive video endoscopy with percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2020.According to the complainant, during the procedure, the button detached from the sheath prior to being released.The procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.

• 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: 10627429
• Report Number: 3005099803-2020-04326
• Device Sequence Number: 3205550
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: 10/31/2021
• Device Model Number: M00568520
• Device Catalogue Number: 6852
• Device Lot Number: 0022940501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1