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

Model Number M00568330

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

(device codes): device code a0501 captures the reportable event of internal bolster detached.

Event Description

It was reported to boston scientific corporation that an endovive low profile replacement button was used during an endoscopy with a percutaneous endoscopic gastrostomy replacement procedure on (b)(6) 2023.During the procedure, upon changing the button, the internal bolster detached.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition was reported to be stable.

Manufacturer Narrative

Block h6 (device codes): device code a0501 captures the reportable event of internal bolster detached.Block h10: one endovive low profile replacement button was returned.Visual analysis of the device revealed that the button dome was punctured.In addition, the bolster was not detached.Therefore, the reported complaint was not confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to the manipulation and/or some technique applied while using the obturator as a support device under 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.

Event Description

It was reported to boston scientific corporation that an endovive low profile replacement button was used during an endoscopy with a percutaneous endoscopic gastrostomy replacement procedure on (b)(6) 2023.During the procedure, upon changing the button, the internal bolster detached.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition was reported to be stable.

• Brand Name: ENDOVIVE LOW PROFILE REPLACEMENT BUTTON
• Type of Device: 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: 16382124
• MDR Text Key: 309612121
• Report Number: 3005099803-2023-00767
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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
• Device Operator: Health Professional
• Device Model Number: M00568330
• Device Catalogue Number: 6833
• Device Lot Number: 0029557277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Sex: Male