MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE LOW PROFILE REPLACEMENT BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M00568290
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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an endovive replacement button was used during a gastrostomy replacement procedure.The procedure date is unknown.During procedure, when an attempt was made to replace the existing button, the internal bolster detached inside patient.The procedure was completed with a new endovive replacement button.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Date of event was approximated to (b)(6) 2022 as no event date was reported.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block e1 (initial reporter address): (b)(6).Block b3 (date of event): date of event was approximated to (b)(6) 2022 as no event date was reported.Block h6 (device codes): device code a0501captures the reportable event of internal bolster detached.Block h10: a one step button was returned.During product analysis it was observed that the internal bolster was not detached.The button dome was punctured.The initial reported event of internal bolster was not confirmed.Based on the condition of the returned device, engineers determined that the problem observed may be related to user manipulation and/or some technique applied while using the obturator as a support device under procedure.The event description evidence that the issue occurred during the insertion which may have been caused by user manipulation.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 the 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 replacement button was used during a gastrostomy replacement procedure.The procedure date is unknown.During procedure, when an attempt was made to replace the existing button, the internal bolster detached inside patient.The procedure was completed with a new endovive replacement button.There were no reported patient complications as a result of this event.Additional information received on february 24, 2022: the internal bolster was detached inside patient.

• Brand Name: ENDOVIVE LOW PROFILE REPLACEMENT BUTTON
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13584739
• Report Number: 3005099803-2022-00955
• Device Sequence Number: 13566464
• Product Code: KNT
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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 Model Number: M00568290
• Device Catalogue Number: 6829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown