MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SECURI-T; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00509161

Device Problem Human-Device Interface Problem (2949)

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

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

Device code a22 captures the reportable event of feeding tube patient removal.

Event Description

It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a percutaneous endoscopic gastrostomy replacement procedure performed on (b)(6) 2023.Post procedure, the patient removed the securi-t on (b)(6) 2023.While the physician was placing another securi-t the internal bolster detached outside the patient.The procedure was completed with a new endovive securi-t device.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a percutaneous endoscopic gastrostomy replacement procedure performed on (b)(6) 2023.Post procedure, the patient removed the securi-t on (b)(6) 2023.While the physician was placing another securi-t the internal bolster detached outside the patient.The procedure was completed with a new endovive securi-t device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device): device code a22 captures the reportable event of feeding tube patient removal.Block h10: the returned endovive securi-t replacement bolster was analyzed.Visual analysis of the device revealed that the internal bolster detached from the tube and an inner ring mark on the bolster presumes that it was attached.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be due to the manipulation or technique used and an excess of force could have contributed to the separation.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.

• Brand Name: ENDOVIVE SECURI-T
• 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: 16303547
• MDR Text Key: 309018014
• Report Number: 3005099803-2023-00404
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00509161
• Device Catalogue Number: 0916
• Device Lot Number: 0029548529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1