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

Model Number	M00568530
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
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 percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2020.According to the complainant, during the procedure, the internal bolster detached inside the patient's stomach.Reportedly, the detached portion was removed.There were no reported patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6 (device codes: problem code 2907 captures the reportable event of internal bolster detached.Block h10: a portion of the one step button was returned.Visual examination of the returned device found that the c-flex tube broken.The button returned with one part of the c-flex tube connected, another part of the c-flex tube stretched and waste from the procedure were presented on the device.Microscope inspection revealed that the c-flex tube is narrowed near the broken area indicating stretching of material and was irregular.With the available information, boston scientific concludes that the c-flex tube broken was inspected under magnification and it showed an irregular shape and stretched, indicating that it was submitted to some tension under procedure.Based on the condition of the returned device, engineers determined that this may be related to some technique applied during procedure.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 percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6)2020.According to the complainant, during the procedure, the internal bolster detached inside the patient's stomach.Reportedly, the detached portion was removed.There were no reported patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 10613128
• Report Number: 3005099803-2020-04321
• Device Sequence Number: 2719890
• Product Code: KGC
• UDI-Device Identifier: 08714729149941
• UDI-Public: 08714729149941
• 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): 07/06/2021

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: 05/12/2022
• Device Model Number: M00568530
• Device Catalogue Number: 6853
• Device Lot Number: 0023838932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 07/06/2021
• 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